Trial Outcomes & Findings for The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain (NCT NCT05870371)
NCT ID: NCT05870371
Last Updated: 2025-04-23
Results Overview
The selected algometer (Commander Algometer, JTECH Medical, Midvale, Utah) was used to measure pain sensitivity through the application of pressure. This device can identify the pressure eliciting a pressure-pain threshold. The pain sensitivity recording was performed at specific points with 3 measurements taken at each. The first measurement was considered tentative and was rejected and the final value was the result from the average of the two remaining measurements. The sites that were selected for the pain pressure threshold measurements were the Mastoid Process, the Bladder 10 (BL 10), the C5-C6 Zygapophyseal Joint, the Upper Trapezius Muscle, the Levator Scapula Muscle, the Deltoid Muscle and the Tibialis Anterior Muscle, bilaterally (left and right).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.
Results posted on
2025-04-23
Participant Flow
The physicians of the pain clinic of the 1st Anesthesiology Clinic of the Aretaeio hospital will evaluate the exclusion criteria for all patients who visit the outpatient clinics and are diagnosed with non-specific neck pain beginning on July 25, 2022, and continuing until the necessary number of participants is reached in accordance with the protocol.The patient will be assessed based on their diagnosis and exclusion criteria in order to participate in the study.
Participant milestones
| Measure |
Feldenkrais Awareness Through Movement
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and systematic or general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae, and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalenes, extensors of the Cervical Spine (splenoid, spinous, semispinalis, longus cephalic and cervical, iliocostalis cervical, multifidus and subscapularis), and sternocleidomastoid.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
76
|
76
|
|
Overall Study
NOT COMPLETED
|
24
|
24
|
Reasons for withdrawal
| Measure |
Feldenkrais Awareness Through Movement
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and systematic or general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae, and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalenes, extensors of the Cervical Spine (splenoid, spinous, semispinalis, longus cephalic and cervical, iliocostalis cervical, multifidus and subscapularis), and sternocleidomastoid.
|
|---|---|---|
|
Overall Study
Nonadherence (missed appointmetns).
|
24
|
24
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and systematic or general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae, and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalenes, extensors of the Cervical Spine (splenoid, spinous, semispinalis, longus cephalic and cervical, iliocostalis cervical, multifidus and subscapularis), and sternocleidomastoid.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Group · 19-29
|
3 Participants
n=76 Participants
|
5 Participants
n=76 Participants
|
8 Participants
n=152 Participants
|
|
Age, Customized
Age Group · 30-39
|
6 Participants
n=76 Participants
|
13 Participants
n=76 Participants
|
19 Participants
n=152 Participants
|
|
Age, Customized
Age Group · 40-49
|
16 Participants
n=76 Participants
|
23 Participants
n=76 Participants
|
39 Participants
n=152 Participants
|
|
Age, Customized
Age Group · 50-59
|
37 Participants
n=76 Participants
|
23 Participants
n=76 Participants
|
60 Participants
n=152 Participants
|
|
Age, Customized
Age Group · 60-70
|
14 Participants
n=76 Participants
|
12 Participants
n=76 Participants
|
26 Participants
n=152 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=76 Participants
|
44 Participants
n=76 Participants
|
99 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=76 Participants
|
32 Participants
n=76 Participants
|
53 Participants
n=152 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
28.1 kg/m^2
STANDARD_DEVIATION 5.2 • n=76 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=76 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.2 • n=152 Participants
|
|
Education Status
None of the Below
|
0 Participants
n=76 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=152 Participants
|
|
Education Status
Primary School Graduate
|
6 Participants
n=76 Participants
|
1 Participants
n=76 Participants
|
7 Participants
n=152 Participants
|
|
Education Status
Secondary School Graduate
|
20 Participants
n=76 Participants
|
11 Participants
n=76 Participants
|
31 Participants
n=152 Participants
|
|
Education Status
Post-Secondary Graduate
|
16 Participants
n=76 Participants
|
15 Participants
n=76 Participants
|
31 Participants
n=152 Participants
|
|
Education Status
University Graduate
|
28 Participants
n=76 Participants
|
37 Participants
n=76 Participants
|
65 Participants
n=152 Participants
|
|
Education Status
Post Graduate and Above
|
6 Participants
n=76 Participants
|
11 Participants
n=76 Participants
|
17 Participants
n=152 Participants
|
|
Employment Status
Unemployed
|
10 Participants
n=76 Participants
|
6 Participants
n=76 Participants
|
16 Participants
n=152 Participants
|
|
Employment Status
Public Sector Employment
|
22 Participants
n=76 Participants
|
21 Participants
n=76 Participants
|
43 Participants
n=152 Participants
|
|
Employment Status
Private Sector Employment
|
25 Participants
n=76 Participants
|
39 Participants
n=76 Participants
|
64 Participants
n=152 Participants
|
|
Employment Status
Self-Employed
|
7 Participants
n=76 Participants
|
1 Participants
n=76 Participants
|
8 Participants
n=152 Participants
|
|
Employment Status
Retirement
|
12 Participants
n=76 Participants
|
9 Participants
n=76 Participants
|
21 Participants
n=152 Participants
|
|
Marital Status
Single
|
14 Participants
n=76 Participants
|
13 Participants
n=76 Participants
|
27 Participants
n=152 Participants
|
|
Marital Status
Married
|
52 Participants
n=76 Participants
|
57 Participants
n=76 Participants
|
109 Participants
n=152 Participants
|
|
Marital Status
Divorced
|
8 Participants
n=76 Participants
|
6 Participants
n=76 Participants
|
14 Participants
n=152 Participants
|
|
Marital Status
Windowed
|
2 Participants
n=76 Participants
|
0 Participants
n=76 Participants
|
2 Participants
n=152 Participants
|
|
Symptom Duration (months)
3-6
|
6 Participants
n=76 Participants
|
8 Participants
n=76 Participants
|
14 Participants
n=152 Participants
|
|
Symptom Duration (months)
6-12
|
5 Participants
n=76 Participants
|
5 Participants
n=76 Participants
|
10 Participants
n=152 Participants
|
|
Symptom Duration (months)
12-24
|
11 Participants
n=76 Participants
|
8 Participants
n=76 Participants
|
19 Participants
n=152 Participants
|
|
Symptom Duration (months)
>24
|
54 Participants
n=76 Participants
|
55 Participants
n=76 Participants
|
109 Participants
n=152 Participants
|
|
Prescribed Medication Use
Yes
|
30 Participants
n=76 Participants
|
21 Participants
n=76 Participants
|
51 Participants
n=152 Participants
|
|
Prescribed Medication Use
No
|
46 Participants
n=76 Participants
|
55 Participants
n=76 Participants
|
101 Participants
n=152 Participants
|
|
Other Diseases
Yes
|
38 Participants
n=76 Participants
|
36 Participants
n=76 Participants
|
74 Participants
n=152 Participants
|
|
Other Diseases
No
|
38 Participants
n=76 Participants
|
40 Participants
n=76 Participants
|
78 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The selected algometer (Commander Algometer, JTECH Medical, Midvale, Utah) was used to measure pain sensitivity through the application of pressure. This device can identify the pressure eliciting a pressure-pain threshold. The pain sensitivity recording was performed at specific points with 3 measurements taken at each. The first measurement was considered tentative and was rejected and the final value was the result from the average of the two remaining measurements. The sites that were selected for the pain pressure threshold measurements were the Mastoid Process, the Bladder 10 (BL 10), the C5-C6 Zygapophyseal Joint, the Upper Trapezius Muscle, the Levator Scapula Muscle, the Deltoid Muscle and the Tibialis Anterior Muscle, bilaterally (left and right).
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Levator Scapulae Muscle Right (Endline)
|
3.21 kg/cm^2
Standard Deviation 1.08
|
2.84 kg/cm^2
Standard Deviation 1.02
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Mastoid Process Left (Baseline)
|
1.24 kg/cm^2
Standard Deviation 0.53
|
1.32 kg/cm^2
Standard Deviation 0.47
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Mastoid Process Left (Endline)
|
1.61 kg/cm^2
Standard Deviation 0.63
|
1.34 kg/cm^2
Standard Deviation 0.51
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Mastoid Process Right (Baseline)
|
1.32 kg/cm^2
Standard Deviation 0.52
|
1.31 kg/cm^2
Standard Deviation 0.43
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Mastoid Process Right (Endline)
|
1.6 kg/cm^2
Standard Deviation 0.57
|
1.32 kg/cm^2
Standard Deviation 0.51
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Bladder 10 Left (Baseline)
|
1.76 kg/cm^2
Standard Deviation 0.87
|
1.75 kg/cm^2
Standard Deviation 0.52
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Bladder 10 Left (Endline)
|
2.08 kg/cm^2
Standard Deviation 0.65
|
1.79 kg/cm^2
Standard Deviation 0.62
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Bladder 10 Right (Baseline)
|
1.85 kg/cm^2
Standard Deviation 0.52
|
1.85 kg/cm^2
Standard Deviation 0.58
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Bladder 10 Right (Endline)
|
2.24 kg/cm^2
Standard Deviation 0.66
|
1.86 kg/cm^2
Standard Deviation 0.51
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Zygoapophyseal Joint Left (Baseline)
|
1.91 kg/cm^2
Standard Deviation 0.58
|
1.9 kg/cm^2
Standard Deviation 0.56
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Zygoapophyseal Joint Left (Endline)
|
2.46 kg/cm^2
Standard Deviation 0.77
|
2.12 kg/cm^2
Standard Deviation 0.6
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Zygoapophyseal Joint Right (Baseline)
|
1.79 kg/cm^2
Standard Deviation 0.52
|
1.83 kg/cm^2
Standard Deviation 0.56
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Zygoapophyseal Joint Right (Endline)
|
2.36 kg/cm^2
Standard Deviation 0.72
|
2.12 kg/cm^2
Standard Deviation 0.6
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Upper Trapezius Muscle Left (Baseline)
|
1.84 kg/cm^2
Standard Deviation 0.64
|
1.74 kg/cm^2
Standard Deviation 0.6
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Upper Trapezius Muscle Left (Endline)
|
2.2 kg/cm^2
Standard Deviation 0.74
|
1.85 kg/cm^2
Standard Deviation 0.68
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Upper Trapezius Muscle Right (Baseline)
|
1.95 kg/cm^2
Standard Deviation 0.76
|
1.79 kg/cm^2
Standard Deviation 0.73
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Upper Trapezius Muscle Right (Endline)
|
2.25 kg/cm^2
Standard Deviation 0.83
|
2.01 kg/cm^2
Standard Deviation 0.78
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Levator Scapulae Muscle Left (Baseline)
|
2.58 kg/cm^2
Standard Deviation 0.84
|
2.56 kg/cm^2
Standard Deviation 0.86
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Levator Scapulae Muscle Left (Endline)
|
3.25 kg/cm^2
Standard Deviation 0.99
|
2.59 kg/cm^2
Standard Deviation 0.8
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Levator Scapulae Muscle Right (Baseline)
|
2.59 kg/cm^2
Standard Deviation 0.94
|
2.66 kg/cm^2
Standard Deviation 0.89
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Deltoid Muscle Left (Baseline)
|
2.2 kg/cm^2
Standard Deviation 0.87
|
2.29 kg/cm^2
Standard Deviation 0.87
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Deltoid Muscle Left (Endline)
|
2.71 kg/cm^2
Standard Deviation 1.01
|
2.39 kg/cm^2
Standard Deviation 0.77
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Deltoid Muscle Right (Baseline)
|
2.44 kg/cm^2
Standard Deviation 0.93
|
2.48 kg/cm^2
Standard Deviation 0.94
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Deltoid Muscle Right (Endline)
|
2.85 kg/cm^2
Standard Deviation 0.83
|
2.5 kg/cm^2
Standard Deviation 0.73
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Tibialis Anterior Muscle Left (Baseline)
|
3.24 kg/cm^2
Standard Deviation 1.02
|
3.87 kg/cm^2
Standard Deviation 1.3
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Tibialis Anterior Muscle Left (Endline)
|
3.83 kg/cm^2
Standard Deviation 1.25
|
3.97 kg/cm^2
Standard Deviation 1.59
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Tibialis Anterior Muscle Right (Baseline)
|
3.31 kg/cm^2
Standard Deviation 1.04
|
3.85 kg/cm^2
Standard Deviation 1.21
|
|
Pain Pressure Threshold Measured by the Commander Algometer, JTECH Medical, Midvale, Utah.
Tibialis Anterior Muscle Right (Endline)
|
4.04 kg/cm^2
Standard Deviation 1.18
|
3.95 kg/cm^2
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The 3D Inertial Motion Moover® Sensor of the company SENSOR medica Technology in Motion (Guidonia Montecelio, Roma, Italia) was used to record cervical range of motion by evaluating cervical spine motion, acceleration and rotation. The sensor was positioned in the center of the patients' forehead on the frontal bone at the level of the glabella and was fastened around the head with the assistance of a strap. Patients were seated with their back straight and their chin parallel to the floor while looking at a target corresponding to their field of view. They were then asked to perform 3 cervical movements (left-right rotation, left-right lateral flexion, flexion-extension) for 3 times each with a pause at each final position. Throughout the process, the examiner's assistant stabilized the patient's trunk and shoulders with their hands and encouraged their constant continuing of each movement.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Rotation Maximum (Baseline)
|
58.22 Degrees
Standard Deviation 9.33
|
63.22 Degrees
Standard Deviation 9.46
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Rotation Maximum (Endline)
|
63.63 Degrees
Standard Deviation 12.1
|
63.77 Degrees
Standard Deviation 8.9
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Rotation Average (Baseline)
|
55.78 Degrees
Standard Deviation 10
|
60.62 Degrees
Standard Deviation 9.84
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Rotation Average (Endline)
|
60.7 Degrees
Standard Deviation 14.69
|
61.61 Degrees
Standard Deviation 9.52
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Lateral Flexion Maximum (Baseline)
|
28.26 Degrees
Standard Deviation 6.83
|
30.4 Degrees
Standard Deviation 6.55
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Lateral Flexion Maximum (Endline)
|
32.07 Degrees
Standard Deviation 7.28
|
31.4 Degrees
Standard Deviation 7.06
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Lateral Flexion Average (Baseline)
|
27.5 Degrees
Standard Deviation 6.67
|
29.5 Degrees
Standard Deviation 6.49
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Lateral Flexion Average (Endline)
|
31.07 Degrees
Standard Deviation 6.9
|
30.73 Degrees
Standard Deviation 7.02
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Flexion Maximum (Baseline)
|
50.31 Degrees
Standard Deviation 10.3
|
51.22 Degrees
Standard Deviation 10.25
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Flexion Maximum (Endline)
|
54.83 Degrees
Standard Deviation 10.46
|
52.67 Degrees
Standard Deviation 8.04
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Flexion Average (Baseline)
|
49.21 Degrees
Standard Deviation 10.77
|
49.36 Degrees
Standard Deviation 10.28
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Flexion Average (Endline)
|
53.66 Degrees
Standard Deviation 10.82
|
51.48 Degrees
Standard Deviation 8.05
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Extention Maximum (Baseline)
|
57.09 Degrees
Standard Deviation 12.31
|
58.26 Degrees
Standard Deviation 12.45
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Extention Maximum (Endline)
|
62.94 Degrees
Standard Deviation 14
|
60.91 Degrees
Standard Deviation 10.86
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Extention Average (Baseline)
|
56.07 Degrees
Standard Deviation 11.85
|
56.1 Degrees
Standard Deviation 12.52
|
|
Cervical Range of Motion Measured by the 3D Inertial Motion Moover® Sensor by SENSOR Medica Technology in Motion (Guidonia Montecelio, Roma, Italia)
Extention Average (Endline)
|
61.55 Degrees
Standard Deviation 13.66
|
59.37 Degrees
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The stabilizer assesses the endurance of deep flexor muscles of the spine using the Cranio-Cervical Flexion Test (CCF Test). The changing pressure will be recorded in an air-filled pressure cell, which is connected to a combined guide and plier. The sack is filled up with air until the 20 mmHg indication is shown. There are 5 levels of motion corresponding to a range of 20-30 mmHg of pressure (Level 1: 22 (decreased endurance), Level 2:24, Level 3: 26, Level 4: 28, Level 5:30 (increased endurance)) with a 30-second break in between. Contraction in each level lasts for 10 seconds. If the patient is unable to endure their position for this amount of time in each level, the test is terminated. The efficiency index is calculated as the quotient where the numerator records the pressure increase in the chamber and the denominator the number of repetitions. The maximum applied pressure sustained for a period of ten seconds is defined as the degree of activation.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (PRESSURE BIOREACTION STABILIZER )
Baseline
|
28.03 mmHg
Standard Deviation 3.07
|
27.68 mmHg
Standard Deviation 3.1
|
|
Endurance of Deep Cervical Flexor Muscles of the Spine Measured by Chattanooga Stabilizer Pressure Biofeedback (PRESSURE BIOREACTION STABILIZER )
Endline
|
29.4 mmHg
Standard Deviation 2.06
|
29.33 mmHg
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) was used. The process involved the measurement of Forced Vital Capacity (FVC). Each patient was given a sterilized nozzle. They were then asked to seal it with their lips and breathe normally through it while their nasal airway was blocked with the use of a clip. Patients inhaled slowly and deeply through the nozzle. Once their lungs were fully filled up with air, they were encouraged to exhale explosively for a minimum duration of 6 seconds.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc
Baseline
|
3.79 Liters
Standard Deviation 0.97
|
4.25 Liters
Standard Deviation 1.17
|
|
Forced Vital Capacity (FVC) Measured by the Spirometer MIR Spirodoc
Endline
|
3.81 Liters
Standard Deviation 0.93
|
4.31 Liters
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) was used. The process involved the measurement of Vital Capacity (VC). Each patient was given a sterilized nozzle. They were then asked to seal it with their lips and breathe normally through it while their nasal airway was blocked with the use of a clip. Patients inhaled slowly and deeply through the nozzle. Once their lungs were fully filled up with air, they were encouraged to exhale slowly and extensively until the lungs were fully emptied.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc
Baseline
|
3.25 Liters
Standard Deviation 0.93
|
3.67 Liters
Standard Deviation 1.37
|
|
Vital Capacity (VC) Measured by the Spirometer MIR Spirodoc
Endline
|
3.34 Liters
Standard Deviation 1
|
3.71 Liters
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.For the evaluation of the respiratory function, a portable spirometer of the MIR company (MIR Spirodoc) was used. The process involved the measurement of Maximum Voluntary Ventilation (MVV). Each patient was given a sterilized nozzle. They were then asked to seal it with their lips and breathe normally through it while their nasal airway was blocked with the use of a clip. This test contains a rhythmical and fast rotation of deep inhalations and exhalations until a distinctive auditory signal is sounded after 15 seconds.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc
Baseline
|
101.88 Liters/minutes
Standard Deviation 30.03
|
118.34 Liters/minutes
Standard Deviation 38.12
|
|
Maximum Voluntary Ventilation (MVV) Measured by the Spirometer MIR Spirodoc
Endline
|
112.16 Liters/minutes
Standard Deviation 34.6
|
122.82 Liters/minutes
Standard Deviation 38.76
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Short Form McGill Pain Questionnaire (SFMPQ) consists of 15 descriptors of pain sensation -11 sensory and 4 affective. The patient rates each description on a four-point intensity scale (0 - no pain, 1 - mild pain, 2 - moderate pain, and 3 - severe pain). The total score ranges from 0 to 45 points, the sensory subscale score from 0 to 33 points and the affective subscale score from 0 to 12 points. The higher the total score on the SFMPQ, the more the pain experience for the patient increases, indicating worse outcome. The Visual Analogue Scale (VAS) and the Present Pain Intensity (PPI) scale are included in the SFMPQ.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Sensory Score (Baseline)
|
10.24 score on a scale
Standard Deviation 6.73
|
9.84 score on a scale
Standard Deviation 5.78
|
|
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Sensory Score (Endline)
|
4.69 score on a scale
Standard Deviation 5
|
5.18 score on a scale
Standard Deviation 5.45
|
|
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Affective Score (Baseline)
|
3.66 score on a scale
Standard Deviation 3.77
|
3.04 score on a scale
Standard Deviation 2.61
|
|
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Affective Score (Endline)
|
1.33 score on a scale
Standard Deviation 2.12
|
1.47 score on a scale
Standard Deviation 2.34
|
|
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Total McGill Score (Baseline)
|
13.89 score on a scale
Standard Deviation 9.86
|
12.88 score on a scale
Standard Deviation 7.76
|
|
Intensity and Quality of Pain Measured by the Short Form McGill Pain Questionnaire.
Total McGill Score (Endline)
|
6.02 score on a scale
Standard Deviation 6.81
|
6.65 score on a scale
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Visual Analogue Scale (VAS) measures pain intensity, asking the patient to rate their current or past level of pain by placing a mark on the line. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The following cut points have been recommended: no pain (0-0,4 cm), mild pain(0,5-4,4 cm), moderate pain (4,5-7,4 cm), and severe pain (7,5-10 cm). A higher score indicates higher pain intensity corresponding to a worse outcome.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Pain Intensity Measured by the Visual Analogue Scale
Baseline
|
4.36 score on a scale
Standard Deviation 1.82
|
4.5 score on a scale
Standard Deviation 2.18
|
|
Pain Intensity Measured by the Visual Analogue Scale
Endline
|
1.77 score on a scale
Standard Deviation 1.71
|
2.25 score on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Present Pain Intensity (PPI) is a six-point rating scale, which ranges from 0 to 5 (0=No pain, 1=Mild, 2 =Annoying, 3=Painful, 4=Horrible, 5=Unbearable). The descriptions are ranked according to increasing intensity so each of them can reflect a higher score. The higher point corresponds to worse outcome.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Present Pain Intesity Measured by the Present Pain Intensity Index.
Baseline
|
1.78 score on a scale
Standard Deviation 0.7
|
1.82 score on a scale
Standard Deviation 0.87
|
|
Present Pain Intesity Measured by the Present Pain Intensity Index.
Endline
|
0.72 score on a scale
Standard Deviation 0.66
|
0.9 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.Neck Disability Index (NDI) consists of ten items, each of them corresponds to six answers from which the patient must choose only one. The lowest score for each item is zero which is assigned as no pain and no functional limitation and the maximum is five which refers to the worst pain and maximum limitation. Therefore, it is understandable that the total score ranges from zero to fifty, with values 0-4 (0%-8%) corresponding to no disability, 5-14 (10%-28%) to mild disability, 15-24 (30%-48%) to moderate disability, 25-34 (50%-68%) to severe and 35-50 (70%-100%) to absolute disability (higher scores mean a worse outcome).
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Neck Disability Measured by the Neck Disability Index
Baseline
|
12.22 score on a scale
Standard Deviation 5.76
|
11.92 score on a scale
Standard Deviation 5.11
|
|
Neck Disability Measured by the Neck Disability Index
Endline
|
6.62 score on a scale
Standard Deviation 5.57
|
5.82 score on a scale
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Hospital Anxiety and Depression Scale (HADS) is a self-report scale of 14 items, which are rated on a four-point scale numbered 0-3. It has two subscales, HADS\_anxiety and HADS\_depression, each of which contains seven items. The total score ranges from 0-21 for each subscale, where values 0-7 correspond to normal depression/anxiety, 8-10 to borderline abnormal depression/anxiety, and 11-21 to abnormal depression/anxiety (higher scores mean a worse outcome).
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
Depression Sub-scale (Baseline)
|
5.68 score on a scale
Standard Deviation 3.63
|
4.86 score on a scale
Standard Deviation 2.72
|
|
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
Depression Sub-scale (Endline)
|
3.57 score on a scale
Standard Deviation 3.19
|
3.41 score on a scale
Standard Deviation 3.05
|
|
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
Anxiety Sub-scale (Baseline)
|
8.67 score on a scale
Standard Deviation 3.82
|
7.82 score on a scale
Standard Deviation 3.69
|
|
Anxiety and Depression Measured by the Hospital Anxiety and Depression Scale
Anxiety Sub-scale (Endline)
|
6.62 score on a scale
Standard Deviation 3.4
|
5.84 score on a scale
Standard Deviation 3.76
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Tampa Scale Kinesiophobia (TSK) is a 17-item questionnaire with a score of 17-68. Four values correspond to each of the 17 questions: 1=Strongly disagree, 2=Disagree to some extent, 3=Agree to some extent, 4=Strongly agree, while the total score is obtained after reversing questions 4, 8, 12 and 16. If the latter amounts to 37 or less then it is associated with a low fear of movement, while on the contrary, 37 or more, with an increased one.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Kinesiophobia Measured by the Tampa Scale Kinesiophobia
Baseline
|
36.71 score on a scale
Standard Deviation 7.58
|
35.01 score on a scale
Standard Deviation 6.94
|
|
Kinesiophobia Measured by the Tampa Scale Kinesiophobia
Endline
|
32.89 score on a scale
Standard Deviation 6.54
|
32.06 score on a scale
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Fear Avoidance Beliefs Questionnaire (FABQ) is a self-referential questionnaire consisting of 16 questions, each of which is scored from zero to six. Therefore, the total score is 96 points. Higher scores correspond to strong perceptions of fear and avoiding pain, indicating a worse outcome. It consists of two subscales; the FABQ\_physical (FABQ-P) composed of four questions and assessing the aforementioned parameters in relation to physical activities and the FABQ\_work (FABQ-W), comprised of seven questions on the same perceptions at work, with scores ranging between 0-24 (15 or greater is considered a high score) and 0-42 (34 or greater is considered a high score with a higher probability of not returning to work) respectively. The remaining five questions aim to distract the patient.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
FABQ_Physical Subscale (Baseline)
|
14.54 score on a scale
Standard Deviation 5.6
|
12.91 score on a scale
Standard Deviation 5.38
|
|
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
FABQ_Physical Subscale (Endline)
|
10.3 score on a scale
Standard Deviation 5.81
|
9.8 score on a scale
Standard Deviation 5.47
|
|
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
FABQ_Work Subscale (Baseline)
|
16.8 score on a scale
Standard Deviation 8.9
|
14.05 score on a scale
Standard Deviation 8.33
|
|
Perception of Fear and Trying to Avoid Pain in Relation to Physical and Work Activities Measured by the Fear Avoidance Beliefs Questionnaire.
FABQ_Work Subscale (Endline)
|
14.56 score on a scale
Standard Deviation 8.8
|
10.57 score on a scale
Standard Deviation 8.59
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Pain Catastrophizing Scale (PCS) scale is a 13-item instrument derived from the definitions of catastrophizing analyzed in the literature and from items from the catastrophizing subscale of the Coping Strategies Questionnaire (CSQ). Participants will be asked to recall past painful experiences and rate each of 13 thoughts or feelings on a five-point scale, where zero (0) corresponds to not at all and four (4) to constantly/all the time. The total score is calculated from the sum of the individual 13 question scores and ranges from 0 to 52. The Rumination subscale score ranges from 0 to 16 points, the Magnification subscale score from 0 to 12 points and the Helplessness subscale score from 0 to 24 points. Higher scores indicate a greater degree of pain catastrophizing meaning a worse outcome. A total score of \>30 represents a clinically significant level of pain catastrophization, while a score of zero corresponds to no pain catastrophizing thoughts.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Rumination (Baseline)
|
7.87 score on a scale
Standard Deviation 4.62
|
7.64 score on a scale
Standard Deviation 4.12
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Rumination (Endline)
|
5.85 score on a scale
Standard Deviation 4.27
|
5.27 score on a scale
Standard Deviation 4.7
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Magnification (Baseline)
|
4.21 score on a scale
Standard Deviation 3.16
|
3.87 score on a scale
Standard Deviation 2.49
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Magnification (Endline)
|
2.55 score on a scale
Standard Deviation 2.64
|
2.41 score on a scale
Standard Deviation 2.43
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Helplessness (Baseline)
|
9.01 score on a scale
Standard Deviation 5.91
|
8.71 score on a scale
Standard Deviation 5.3
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
Helplessness (Endline)
|
5.62 score on a scale
Standard Deviation 5.16
|
5.51 score on a scale
Standard Deviation 4.98
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
PCS Total Score (Baseline)
|
21.09 score on a scale
Standard Deviation 12.28
|
20.22 score on a scale
Standard Deviation 10.6
|
|
Pain Catastrophizing Measured by the Pain Catastrophizing Scale.
PCS Total Score (Endline)
|
14.02 score on a scale
Standard Deviation 10.93
|
13.2 score on a scale
Standard Deviation 11.25
|
SECONDARY outcome
Timeframe: Participants were assessed before (at baseline) and after (five weeks) the completion of the interventions.The Short Form (SF)-12 Health Survey is the short form of the SF-36 which contains 12 out of 36 questions. It assesses the parameters physical functioning (PF), physical and emotional role (role physical/RP, role emotional/RE) and mental health (MH), using two items. The parameters bodily pain (BP), general health (GH), social functioning (SF) and vitality (VT) are represented by a single item. All 12 items are used to measure the physical and mental component summary scores (PCS-12 and MCS-12). Scores in subscales range from 0 to 100 and higher scores are indicative of better mental and physical health status and better outcome. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Quality of Life Measured by the Short Form 12 Health Survey.
Physical Component Summary Score (Baseline)
|
44.98 score on a scale
Standard Deviation 9.86
|
45.75 score on a scale
Standard Deviation 7.54
|
|
Quality of Life Measured by the Short Form 12 Health Survey.
Physical Component Summary Score (Endline)
|
49.97 score on a scale
Standard Deviation 7.47
|
50.41 score on a scale
Standard Deviation 7.01
|
|
Quality of Life Measured by the Short Form 12 Health Survey.
Mental Component Summary Score (Baseline)
|
43.83 score on a scale
Standard Deviation 9.46
|
46.89 score on a scale
Standard Deviation 8.46
|
|
Quality of Life Measured by the Short Form 12 Health Survey.
Mental Component Summary Score (Endline)
|
52.16 score on a scale
Standard Deviation 7.96
|
51.35 score on a scale
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: Participants were assessed after the completion of the interventions (five weeks).The Global Perceived Effect (GPE) cale was used to assess the perceived change of the subject's health condition. It asks the patient to rate how much their condition has worsened or improved relatively to another predetermined point in time (before the treatments). It is a numerical scale which consists of only one question with 5 possible answers. Values range between 1-5 with the higher score indicating worse outcome.
Outcome measures
| Measure |
Feldenkrais Awareness Through Movement
n=76 Participants
Application of the Feldenkrais Awareness Through Movement technique in group sessions.
Feldenkrais Awareness Through Movement technique: 10 group sessions, 50 minutes each, over a period of five weeks, which will include the application of the Feldenkrais Awareness Through Movement technique
|
Acupuncture and Stretching
n=76 Participants
Acupuncture protocol in combination with stretching exercises.
Acupuncture: 10 sessions, two per week, of 25 minutes acupuncture each, which will include the insertion of a sterile disposable needle into standardized local, regional, and general acupuncture points that modify pain behavior in area of Cervical Spine.
Stretching: 10 sessions, two per week, of 15 minutes stretching each, which will include lateral flexion and counterrotation of the head performed for the upper part of the trapezius and the anterior scalene, lateral flexion and corresponding rotation for the levator scapulae and flexion for the extensors of the Cervical Spine. The following muscles will be applied: upper trapezius, levator scapulae, scalene, sternocleidomastoid, cervical extensor muscles (splenius, spinalis, semispinalis, longissimus capitis and cervicis and iliocostalis cervicis, multifidi and suboccipital).
|
|---|---|---|
|
Global Perceived Effect Measured by the Global Perceived Effect Scale
|
1.49 score on a scale
Standard Deviation 0.58
|
1.78 score on a scale
Standard Deviation 0.64
|
Adverse Events
Feldenkrais Awareness Through Movement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acupuncture and Stretching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. George Georgoudis
Musculoskeletal Research Laboratory (MRL) of Physiotherapy Department University of West Attica, Athens, Greece
Phone: +30-210-5387487
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place