Trial Outcomes & Findings for A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain (NCT NCT03236779)
NCT ID: NCT03236779
Last Updated: 2021-01-26
Results Overview
Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Dry Needling (DN) Arm
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
38
|
30
|
|
Overall Study
NOT COMPLETED
|
13
|
21
|
Reasons for withdrawal
| Measure |
Dry Needling (DN) Arm
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
21
|
Baseline Characteristics
A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain
Baseline characteristics by cohort
| Measure |
Dry Needling (DN) Arm
n=51 Participants
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
n=51 Participants
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
Kuwait
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeksParticipants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Outcome measures
| Measure |
Dry Needling (DN) Arm
n=51 Participants
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
n=51 Participants
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
|---|---|---|
|
Foot Health Status Questioner (FHSQ) PAIN
baseline
|
38.8 score on a scale
Standard Deviation 18.8
|
40.4 score on a scale
Standard Deviation 21.9
|
|
Foot Health Status Questioner (FHSQ) PAIN
4 weeks
|
73.4 score on a scale
Standard Deviation 27.7
|
71.9 score on a scale
Standard Deviation 25.7
|
|
Foot Health Status Questioner (FHSQ) PAIN
8 weeks
|
70.1 score on a scale
Standard Deviation 28.4
|
67.4 score on a scale
Standard Deviation 26.8
|
|
Foot Health Status Questioner (FHSQ) PAIN
12 weeks
|
66.8 score on a scale
Standard Deviation 24.8
|
63.6 score on a scale
Standard Deviation 26.8
|
|
Foot Health Status Questioner (FHSQ) PAIN
26 weeks
|
68.8 score on a scale
Standard Deviation 25.3
|
67.1 score on a scale
Standard Deviation 27.1
|
|
Foot Health Status Questioner (FHSQ) PAIN
52 weeks
|
68.4 score on a scale
Standard Deviation 25.1
|
73.1 score on a scale
Standard Deviation 29.0
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeksParticipants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
Outcome measures
| Measure |
Dry Needling (DN) Arm
n=51 Participants
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
n=51 Participants
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
|---|---|---|
|
Foot Health Status Questioner (FHSQ) PAIN
baseline
|
38.8 score on a scale
Standard Deviation 18.8
|
40.4 score on a scale
Standard Deviation 21.9
|
|
Foot Health Status Questioner (FHSQ) PAIN
4 weeks
|
73.4 score on a scale
Standard Deviation 27.7
|
71.9 score on a scale
Standard Deviation 25.7
|
|
Foot Health Status Questioner (FHSQ) PAIN
8 weeks
|
70.1 score on a scale
Standard Deviation 28.4
|
67.4 score on a scale
Standard Deviation 26.8
|
|
Foot Health Status Questioner (FHSQ) PAIN
12 weeks
|
66.8 score on a scale
Standard Deviation 24.8
|
63.6 score on a scale
Standard Deviation 26.8
|
|
Foot Health Status Questioner (FHSQ) PAIN
26 weeks
|
68.8 score on a scale
Standard Deviation 25.3
|
67.1 score on a scale
Standard Deviation 27.1
|
|
Foot Health Status Questioner (FHSQ) PAIN
52 weeks
|
68.4 score on a scale
Standard Deviation 25.1
|
73.1 score on a scale
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable
Outcome measures
| Measure |
Dry Needling (DN) Arm
n=51 Participants
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
n=51 Participants
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
|---|---|---|
|
VAS Maximum
baseline 1st session
|
7.6 units on a scale
Standard Deviation 2.0
|
7.5 units on a scale
Standard Deviation 2.3
|
|
VAS Maximum
2nd session
|
6.2 units on a scale
Standard Deviation 2.3
|
5.5 units on a scale
Standard Deviation 2.9
|
|
VAS Maximum
3rd session
|
5.4 units on a scale
Standard Deviation 2.6
|
5.3 units on a scale
Standard Deviation 3.1
|
|
VAS Maximum
4th session
|
4.9 units on a scale
Standard Deviation 2.9
|
4.5 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.
Outcome measures
| Measure |
Dry Needling (DN) Arm
n=51 Participants
Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
Percutaneous Needle Electrolysis (PNE) Arm
n=51 Participants
The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
|
|---|---|---|
|
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
4 weeks
|
0.78 units on a scale
Standard Deviation 0.22
|
0.76 units on a scale
Standard Deviation 0.24
|
|
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
8 weeks
|
0.72 units on a scale
Standard Deviation 0.23
|
0.74 units on a scale
Standard Deviation 0.23
|
|
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
12 weeks
|
0.64 units on a scale
Standard Deviation 0.30
|
0.70 units on a scale
Standard Deviation 0.27
|
|
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
26 weeks
|
0.65 units on a scale
Standard Deviation 0.29
|
0.73 units on a scale
Standard Deviation 0.27
|
|
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
52 weeks
|
0.66 units on a scale
Standard Deviation 0.27
|
0.77 units on a scale
Standard Deviation 0.25
|
|
The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
baseline
|
0.63 units on a scale
Standard Deviation 0.23
|
0.67 units on a scale
Standard Deviation 0.22
|
Adverse Events
Dry Needling
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Percutaneous Needle Electrolysis
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dry Needling
n=51 participants at risk
Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries).
|
Percutaneous Needle Electrolysis
n=51 participants at risk
The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
unable to tolerate pain
|
17.6%
9/51 • Number of events 9 • 1 year follow up
Unable to tolerate pain of the treatment
|
27.5%
14/51 • Number of events 14 • 1 year follow up
Unable to tolerate pain of the treatment
|
Additional Information
Dr. Pablo Herrero Gallego. PT, PhD.
Head of iPhysio Research Group. Editor-in-Chief Journal of Invasive Techniques in Physical Therapy
Phone: (+34) 646168248
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place