Myofascial Pain Syndrome of NeckNCT04660292
Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain
A study testing Maitland's mobilization and Traditional Physical therapy in people with Myofascial Pain Syndrome of Neck, run by Riphah International University at 1 site in Pakistan.
Trial summary
Myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points and local and referred pain patterns. Chronic neck pain is responsible for the involvement of joints, ligaments, fascia and connective tissue as well. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Myofascial Pain Syndrome of Neck
- What is being tested?
- Maitland's mobilization and Traditional Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 30 Oct 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
- Patients age between 25-45 years old,
- 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 2 cm on a 10 cm 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 side-bending); ---Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles were included in this study.
Who cannot join
- A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);
- Systemic diseases such as fibromyalgia, systemic erythematous lupus and arthritis;
- Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);
- Concomitant medical diagnosis of any primary headache (tension type or migraine);
- Cervical spine surgery; and clinical diagnosis of cervical radiculopathy or myelopathy
Trial locations and contacts
1 site in 1 country.
About this study
Myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points and local and referred pain patterns. Chronic neck pain is responsible for the involvement of joints, ligaments, fascia and connective tissue as well. The objective of this study was to assess the impacts of Maitland's mobilization in patients with myofacial chronic neck pain. Maitland's mobilization is one of the most common manual therapy approaches used by physiotherapists. Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.
In this randomized, placebo treatment controlled trial, 30 patients consecutively aged 25-45 years meeting inclusion criteria were isolated into two groups. The study group was treated with Maitland's mobilization consistently for 8 weeks while the control group got placebo treatment for a similar time frame. Visual analog Scale (VAS), Neck disability index (NDI) and cervical range of motion (ROM) questionnaire was filled by patients before, intermediate and after the intervention to evaluate the severity of pain, functional ability and range of motion.
- Conditions
- Myofascial Pain Syndrome of Neck
- Being tested
- Maitland's mobilization, Traditional Physical therapy
- Keywords
- Neck Pain, Manual mobilization, Isometric exercise, Triger points, Visual analog scale
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maitland's mobilizationOther
Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.It has Five grades
Traditional Physical therapyOther
BASELINE TREATMENT INCLUDES TENS and Hot PACKS
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The study group was treated with Maitland mobilization and manipulation techniques including postero-anterior Maitland mobilization for C1-C2, Maitland lateral PA glide for C3-C6 and Maitland thrust manipulation for cervico-thoracic junction. Frequency of mobilization was 2 days a week for 4 weeks. While intensity of mobilization was grade 3 and 4 based on the Maitland concept.13 Time of oscillations was 2 or 3 oscillations in a second for 1 to 2 minutes. Receives: Other: Maitland's mobilization |
| Control Group | Active comparator | While placebo treatment with conventional physiotherapy (active exercises-10 repetitions in all direction in pain free range, isometrics 5-10 seconds brief but maximum contraction each held for 5-16 seconds for flexors, extensors, side flexors and rotators)14 without gliding, oscillations and thrust were recommended for the control group.The placebo group was treated with baseline treatment including TENS 10 minutes and moist hot packs in sitting position for 15 minutes on cervical region in with head resting on table with a pillow. Receives: Other: Traditional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Its a pain rating Scale Scoring between 0-10.O means no pain 10 means worse pain
Measured: 2 months
Neck disability Index
Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Aug 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome of NeckStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Shabbir, Riphah International University
- Investigators
- Maryam Shabbir, PhD*, Principal investigator, Riphah International UniversityNaveed Arshad, Mphil, Principal investigator, Islamabad Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660292
- Sponsor's protocol ID
- PT-Associate-MARYAM SHABBIR
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh YL, Kao MJ, Kuan TS, Chen SM, Chen JT, Hong CZ. Dry needling to a key myofascial trigger point may reduce the irritability of satellite MTrPs. Am J Phys Med Rehabil. 2007 May;86(5):397-403. doi: 10.1097/PHM.0b013e31804a554d.
PubMed 17449984Leon-Hernandez JV, Martin-Pintado-Zugasti A, Frutos LG, Alguacil-Diego IM, de la Llave-Rincon AI, Fernandez-Carnero J. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. 2016 Jul 11;20(5):422-431. doi: 10.1590/bjpt-rbf.2014.0176.
PubMed 27410163Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
PubMed 28158962Tekin 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 23138883Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
PubMed 26304789Clewley D, Flynn TW, Koppenhaver S. Trigger point dry needling as an adjunct treatment for a patient with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 2014 Feb;44(2):92-101. doi: 10.2519/jospt.2014.4915. Epub 2013 Nov 21.
PubMed 24261931Blanpied 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 28666405
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04660292
- Acronym / sponsor ID
- PT-Associate-MARYAM SHABBIR
- Conditions
- Myofascial Pain Syndrome of Neck
- Keywords
- Neck Pain, Manual mobilization, Isometric exercise, Triger points, Visual analog scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 Dec 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.
Myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points and local and referred pain patterns. Chronic neck pain is responsible for the involvement of joints, ligaments, fascia and connective tissue as well. The objective of this study was to assess the impacts of Maitland's mobilization in patients with myofacial chronic neck pain. Maitland's mobilization is one of the most common manual therapy approaches used by physiotherapists. Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.
In this randomized, placebo treatment controlled trial, 30 patients consecutively aged 25-45 years meeting inclusion criteria were isolated into two groups. The study group was treated with Maitland's mobilization consistently for 8 weeks while the control group got placebo treatment for a similar time frame. Visual analog Scale (VAS), Neck disability index (NDI) and cervical range of motion (ROM) questionnaire was filled by patients before, intermediate and after the intervention to evaluate the severity of pain, functional ability and range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Maitland's mobilizationThe study group was treated with Maitland mobilization and manipulation techniques including postero-anterior Maitland mobilization for C1-C2, Maitland lateral PA glide for C3-C6 and Maitland thrust manipulation for cervico-thoracic junction. Frequency of mobilization was 2 days a week for 4 weeks. While intensity of mobilization was grade 3 and 4 based on the Maitland concept.13 Time of oscillations was 2 or 3 oscillations in a second for 1 to 2 minutes. |
| Control Group | Active comparator | Other: Traditional Physical therapyWhile placebo treatment with conventional physiotherapy (active exercises-10 repetitions in all direction in pain free range, isometrics 5-10 seconds brief but maximum contraction each held for 5-16 seconds for flexors, extensors, side flexors and rotators)14 without gliding, oscillations and thrust were recommended for the control group.The placebo group was treated with baseline treatment including TENS 10 minutes and moist hot packs in sitting position for 15 minutes on cervical region in with head resting on table with a pillow. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients age between 25-45 years old,
- 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 2 cm on a 10 cm 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;
Key exclusion criteria (5 listed)
- A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);
- Systemic diseases such as fibromyalgia, systemic erythematous lupus and arthritis;
- Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);
- Concomitant medical diagnosis of any primary headache (tension type or migraine);
- Cervical spine surgery; and clinical diagnosis of cervical radiculopathy or myelopathy
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 |
|---|---|---|
| Maitland's mobilizationMaitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.It has Five grades | Other | Study Group |
| Traditional Physical therapyBASELINE TREATMENT INCLUDES TENS and Hot PACKS | Other | Control Group |
Primary outcome
Visual Analogue Scale
Time frame: 2 months
Its a pain rating Scale Scoring between 0-10.O means no pain 10 means worse pain
Neck disability Index
Time frame: 2 months
Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.
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 9 Dec 2020.
- Background: PubMed 17449984Hsieh YL, Kao MJ, Kuan TS, Chen SM, Chen JT, Hong CZ. Dry needling to a key myofascial trigger point may reduce the irritability of satellite MTrPs. Am J Phys Med Rehabil. 2007 May;86(5):397-403. doi: 10.1097/PHM.0b013e31804a554d.
- Background: PubMed 27410163Leon-Hernandez JV, Martin-Pintado-Zugasti A, Frutos LG, Alguacil-Diego IM, de la Llave-Rincon AI, Fernandez-Carnero J. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. 2016 Jul 11;20(5):422-431. doi: 10.1590/bjpt-rbf.2014.0176.
- Background: PubMed 28158962Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
- 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.
- Background: PubMed 26304789Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
- Background: PubMed 24261931Clewley D, Flynn TW, Koppenhaver S. Trigger point dry needling as an adjunct treatment for a patient with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 2014 Feb;44(2):92-101. doi: 10.2519/jospt.2014.4915. Epub 2013 Nov 21.
- 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.
- 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
Naveed Arshad, Mphil principal investigator
Islamabad Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maitland's mobilization and Traditional Physical therapy in people with Myofascial Pain Syndrome of Neck, 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 6 inclusion and 5 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 9 Dec 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?
Visual Analogue Scale (time frame: 2 months). The study lists 2 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 NCT04660292, which also lists 7 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 9 Dec 2020.