Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy
NCT ID: NCT03328351
Last Updated: 2017-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2016-12-18
2017-08-24
Brief Summary
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Detailed Description
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The sample size was calculated using G\*power 3.1(F test, analysis of variance \[ANOVA\]: repeated measure, within between interaction, and a priori: compute required sample size). A result of 10 participants (treatment group=5 and sham group=5) was used to calculate the effect size (ES) of 0.44 for the pressure pain threshold on the cervical spine after the intervention(immediate effect) between group. The power estimated for ANOVA for the two group with a significance of 0.05 revealed that a total sample size of 28 participants was necessary to obtain a power of 0.80. . a minimum of 14 needed to be recruited in this study Participants with unilateral neck pain and radiating symptoms to upper extremity of more than three months were recruited from King Abdul-Aziz Hospital and East Jeddah general hospital in Jeddah, Saudia Arabia All patients signed a consent form before they participate in the study after explaining all procedures to them. The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: PGS-20160-30-142) and was approved by ministry of health at Saudia Arabia (IRB number: H-02J-002). All electronic data pertinent to the patients were being saved in a secured laptop, whereas the paper document will be kept in a locked cabinet.
Data analysis:
All statistical analysis was performed using IBM SPSS version 20 (Armonk, NY: IBM Corp). Significance levels will be set at p ≤ 0.05. Mean and standard deviation will be calculated as descriptive statistics. One-way repeated measures analysis of variance (ANOVA) and post hoc comparison, if needed will calculate the differences in the outcome measures: Quantitive sensory testing (QST), pain intensity, and active CROM
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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manual group
1. The Manual therapy (Mobilization):
1. Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set
2. Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set.
2. Strengthening Exercises for deep neck flexor muscle
manual therapy
1. Manual therapy: One of the following techniques was used for the treatment group based on the patients' response (i.e centralization and reduction of symptoms).
1. Cervical postero-anterior vertebral mobilization glides:
a central posteranterior (PA) or unilateral PA oscillatory pressure of grade III on the patient's most symptomatic level for 2 minute and 3 sets .
2. Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets.
2. Strengthening Exercises:
for deep neck flexor muscles for 10 seconds and repeating it for 10 times.
sham group
1. Superficial soft tissue massage
2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .
Superficial soft tissue massage
1\. Superficial soft tissue massage: The researcher applied a superficial effleurage massage without moving the deeper tissue for 2 minutes for 3 sets
Strengthening Exercises:
for deep neck flexor muscles for 10 seconds and repeating it for 10 times
Interventions
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manual therapy
1. Manual therapy: One of the following techniques was used for the treatment group based on the patients' response (i.e centralization and reduction of symptoms).
1. Cervical postero-anterior vertebral mobilization glides:
a central posteranterior (PA) or unilateral PA oscillatory pressure of grade III on the patient's most symptomatic level for 2 minute and 3 sets .
2. Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets.
2. Strengthening Exercises:
for deep neck flexor muscles for 10 seconds and repeating it for 10 times.
Superficial soft tissue massage
1\. Superficial soft tissue massage: The researcher applied a superficial effleurage massage without moving the deeper tissue for 2 minutes for 3 sets
Strengthening Exercises:
for deep neck flexor muscles for 10 seconds and repeating it for 10 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. age :between 35 to 65 years old.
3. Presence 3 out of 4 positive findings:
* spurling test.
* distraction test,
* upper limb neurodynamic test for median nerve
* ipsilateral cervical rotation test less than 60 degrees.
Exclusion Criteria
2. tumor.
3. metabolic disease (DM,resting blood pressure are greater than 140/90).
4. rheumatoid arthritis.
5. history of whiplash injury.
6. myelopathy.
7. pregnancy.
8. history of cervical or thoracic surgery
9. generalized neurological disorders .
10. leg surgery or disease (fracture) -
35 Years
65 Years
ALL
No
Sponsors
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Imam Abdulrahman Bin Faisal University
OTHER
Responsible Party
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Principal Investigators
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Ali M Alshami, PHD
Role: STUDY_DIRECTOR
Imam Abdulrahman Bin Faisal University
Locations
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East jeddah general hospital
Jeddah, , Saudi Arabia
king Abdulaziz hospital
Jeddah, , Saudi Arabia
Countries
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References
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Alshami AM, Bamhair DA. Effect of manual therapy with exercise in patients with chronic cervical radiculopathy: a randomized clinical trial. Trials. 2021 Oct 18;22(1):716. doi: 10.1186/s13063-021-05690-y.
Other Identifiers
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Dammam University
Identifier Type: -
Identifier Source: org_study_id