- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04568915
Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain
September 25, 2020 updated by: Riphah International University
Comparison Between Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain
The purpose of my research is to compare the effects of dry needling and Maitland mobilization in chronic myofacial neck pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To distinguish which technique is most effective in pain reduction and range gain because in chronic cases there is involvement of fascia, muscles and joints due to prolonged stress on any of the component affecting the other.
Hence, the study will help to design a treatment plan with more accurate intervention.
After sample collection according to selection criteria treatment sessions will be given to both groups for 6 weeks.
Data will be collected at baseline, then after 2 weeks, 4 weeks and at 8th week.
Tools for data collection are Visual analogue scale, Neck Disability Index and Goniometer.
For statistical analysis SPSS 22 will be used.
Intra group difference will be calculated by repeated measurement ANOVA / Friedman test and inter group analysis will be done by Independent sample t test.
Descriptive data will be expressed in terms of frequency and proportions.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lahore, Pakistan, 54000
- Riphah IU
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Bilateral pain involving the upper trapezius and elevator muscle of the scapula;
- Duration of pain of at least 3 months;
- A pain intensity corresponding to at least 20 mm on a 100 mm visual analogue scale (VAS)
- Neck pain with symptoms provoked by either neck postures or neck movement;
- Pain localized at least in the cervical and occipital regions but not in the orofacial region;
- Neck disability index (NDI) greater than or equal to 15 points;
- Restricted cervical range of movements (flexion, extension, rotation, and sidebending); (i) Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles
Exclusion Criteria:
- Any signs, symptoms, or history of the following diseases:
- Orofacial pain and temporo-mandibular disorders
- A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);
- Systemic diseases such as fibromyalgia, systemic erythematous lupus, and arthritis; (d) Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);
- Concomitant medical diagnosis of any primary headache (tension type or migraine);
- Unilateral neck pain;
- Cervical spine surgery;
- Clinical diagnosis of cervical radiculopathy or myelopathy;
- Needle phobia;
- History of previous physical therapy intervention for the cervical region in last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Dry Needling-Group
Tens, Stretching, Strengthening(girdle), Neck Isometrics, DN
|
TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, DN
|
|
ACTIVE_COMPARATOR: Maitland-Group
Tens Stretching, Strengthening(girdle), Neck Isometrics, Maitland joint mobilization
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TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, Maitland joint mobilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: 4 months
|
Standard Goniometer will be used.Higher score shows improvement.
|
4 months
|
|
Disability
Time Frame: 4 months
|
Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5.
If all ten sections are completed the score is calculated as follows: Example:16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum Detectable Change (90% confidence): 5 points or 10 %points
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4 months
|
|
Numeric Pain Rating Scale NPRS
Time Frame: 4 months
|
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale.
The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004249. doi: 10.1002/14651858.CD004249.pub3.
- Davidoff RA. Trigger points and myofascial pain: toward understanding how they affect headaches. Cephalalgia. 1998 Sep;18(7):436-48. doi: 10.1046/j.1468-2982.1998.1807436.x.
- Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. doi: 10.1053/apmr.2002.32155.
- Campa-Moran I, Rey-Gudin E, Fernandez-Carnero J, Paris-Alemany A, Gil-Martinez A, Lerma Lara S, Prieto-Baquero A, Alonso-Perez JL, La Touche R. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study. Pain Res Treat. 2015;2015:327307. doi: 10.1155/2015/327307. Epub 2015 Nov 10.
- Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
- Graff-Radford SB, Reeves JL, Jaeger B. Management of chronic head and neck pain: effectiveness of altering factors perpetuating myofascial pain. Headache. 1987 Apr;27(4):186-90. doi: 10.1111/j.1526-4610.1987.hed2704186.x. No abstract available.
- Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 15, 2019
Primary Completion (ACTUAL)
June 20, 2020
Study Completion (ACTUAL)
June 28, 2020
Study Registration Dates
First Submitted
September 25, 2020
First Submitted That Met QC Criteria
September 25, 2020
First Posted (ACTUAL)
September 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 25, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-OMPT/Spring19/030 Momna
- Momna Ghaffar (OTHER: Riphah)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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