Myofacial PainNCT04568915
Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain
A study testing Dry Needling and Maitland Mobilization in people with Myofacial Pain and Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of my research is to compare the effects of dry needling and Maitland mobilization in chronic myofacial neck pain Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Myofacial Pain, Neck Pain
- What is being tested?
- Dry Needling and Maitland Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2019to 28 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Myofacial Pain, Neck Pain
- Being tested
- Dry Needling, Maitland Mobilization
- Keywords
- Neck Pain, Myofacial Pain
- Medical subject headings
- Facial Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, DN
Maitland MobilizationOther
TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, Maitland joint mobilization
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling-Group | Experimental | Tens, Stretching, Strengthening(girdle), Neck Isometrics, DN Receives: Other: Dry Needling |
| Maitland-Group | Active comparator | Tens Stretching, Strengthening(girdle), Neck Isometrics, Maitland joint mobilization Receives: Other: Maitland Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale NPRS
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).
Measured: 4 months
Range of Motion
Standard Goniometer will be used.Higher score shows improvement.
Measured: 4 months
Disability
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start15 Sep 2019
- Primary completion20 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568915
- Sponsor's protocol ID
- MS-OMPT/Spring19/030 Momna
- Other IDs
- Momna Ghaffar
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20091561Davidoff 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.
PubMed 9793695Borg-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.
PubMed 11973695Campa-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.
PubMed 26640708Blanpied 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.
PubMed 28666405Dunning 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.
PubMed 25143704Graff-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.
PubMed 3597072Tekin 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.
PubMed 23138883
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04568915
- Acronym / sponsor ID
- MS-OMPT/Spring19/030 Momna
- Conditions
- Myofacial Pain, Neck Pain
- Keywords
- Neck Pain, Myofacial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of my research is to compare the effects of dry needling and Maitland mobilization in chronic myofacial neck pain
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling-Group | Experimental | Other: Dry NeedlingTens, Stretching, Strengthening(girdle), Neck Isometrics, DN |
| Maitland-Group | Active comparator | Other: Maitland MobilizationTens Stretching, Strengthening(girdle), Neck Isometrics, Maitland joint mobilization |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingTENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, DN | Other | Dry Needling-Group |
| Maitland MobilizationTENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, Maitland joint mobilization | Other | Maitland-Group |
Primary outcome
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).
Range of Motion
Time frame: 4 months
Standard Goniometer will be used.Higher score shows improvement.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Background: PubMed 20091561Gross 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.
- Background: PubMed 9793695Davidoff 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.
- Background: PubMed 11973695Borg-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.
- Background: PubMed 26640708Campa-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.
- Background: PubMed 28666405Blanpied 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.
- Background: PubMed 25143704Dunning 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.
- Background: PubMed 3597072Graff-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.
- Background: PubMed 23138883Tekin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Shabbir, PHD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Maitland Mobilization in people with Myofacial Pain and Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale NPRS (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568915, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.