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Chronic Non-specific Neck PainNCT05947214

Comparative Effects of Myofascial Decompression and Positional Release Therapies in Chronic Non-specific Neck Pain

A study testing Myofascial Decompression Therapy and positional Release Therapy in people with Chronic Non-specific Neck Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nonspecific neck pain is defined as a neck pain not attributable to an identifiable, known specific pathology. The frequency of neck pain as found to be 84% which is exceptionally high and these are the majority of the individuals with neck pain that present to physiotherapy. Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Chronic Non-specific Neck Pain
What is being tested?
Myofascial Decompression Therapy and positional Release Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
3 Mar 2023to 4 Oct 2023
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Neck patients age 25 to 50 years.
  • Both male and female genders.
  • Mild to moderate back pain with NPRS pain score value of between more than 6/10.
  • Pain from at least past three months (12 weeks).
  • Trigger points within the muscle.

Who cannot join

  • Diagnosis of systemic metabolic and/or neurological disorders.
  • Patients with sensory impairments, such as diabetic sensory neuropathy. Neuropathic pain.
  • Any referred pain or neurological involvement in lower limbs is not included.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah international university

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Comparative Effects of Myofascial Decompression and Positional Release Therapies on Pain, Range of Motion and Functional Disability in Chronic Non-specific Neck Pain

Nonspecific neck pain is defined as a neck pain not attributable to an identifiable, known specific pathology. The frequency of neck pain as found to be 84% which is exceptionally high and these are the majority of the individuals with neck pain that present to physiotherapy. In many cases, various factors contribute to the development of non-specific neck pain. These might include physical strain at work, such as working on something above you or sitting at a desk without moving enough. Emotional stress, like worries and anxiety about family or work, often plays an important role. It is thought that in some cases the cause may be an over-stretch (sprain) of a ligament or muscle. In other cases the cause may be a minor problem with a disc between two spinal bones (vertebrae), or a minor problem with a small facet joint between two vertebrae. Objective of this study will be to compare the effects of myofascial decompression and positional release therapies on pain, range of motion and functional disability in chronic nonspecific neck pain.

Read the detailed description

Neck pain is one of the most common and painful musculoskeletal conditions. Point prevalence ranges from 6% to 22% and up to 38% of the elderly population, while lifetime prevalence ranges from 2% to 71%. For the majority of the neck disorders there is an absence of an identifiable underlying disease or abnormal anatomical structure. From this perspective .NS-NP is mainly 'diagnosed' on the basis of clinical grounds, provided there are no features to suggest a specific or more serious condition. The symptoms of nonspecific neck pain are similar to those of whiplash associated disorders (WAD) grade I and II but there is no traumatic event involved. Nonspecific neck pain (NP) is defined as pain in the posterior and lateral aspect of the neck between the superior nuchal line and the spinous process of the first thoracic vertebra with no signs or symptoms of major structural pathology and no or minor to major interference with activities of daily life as well as with the absence of neurological signs and specific pathologies. Chronic nonspecific neck pain is diagnosed as cervical pain without a known pathological basis as the underlying cause of the complaints. Some symptoms are limited cervical spine mobility and neck muscles weakness, which may be often related to other problems, such as, vertebral, neck or shoulder impaired function, and mental and physical stress at work. The natural course of non-specific neck pain remains unclear. While it is often self-limiting within a few weeks of onset, it can severely limit daily functioning, induce substantial medical consumption and result in prolonged sick leave and disability leading chronic nonspecific neck pain if pain duration is more than three months. As a consequence, it places a heavy burden on individuals, employers and health care services. Nonspecific neck pain is defined in the European guidelines for the management of chronic nonspecific neck pain that is not attributable to a recognizable, specific pathology (e.g., infection, tumor, osteoporosis, fracture, structural deformity, and inflammatory diseases, such as ankylosing spondylitis, radicular syndrome. Characteristic of chronic nonspecific neck pain are heavy pain, worsening with exertion and relieve with rest. In some cases the cause may be sprain or overstretch of a ligament or muscles. Nonspecific neck belongs to the group of musculoskeletal disorders, which include diverse conditions affecting muscles, bones, and/or joints of the limbs or the spine. As for most other musculoskeletal disorders, nonspecific neck is multifactorial. A variety of different types of exercise have been explored to treat chronic neck pain, including low-to-moderate intensity aerobic exercise, high intensity aerobic exercise, stretching exercise and muscular strength exercises and isometrics. However, the most effective form of exercise as a method of rehabilitation non-specific neck pain is unknown reflecting its complexity and more research is require. The rationale of the study is to compare the effects of myofascial decompression and positional release therapies on pain, range of motion and functional disability in chronic nonspecific neck pain. The main purpose of myofascial decompression therapy and positional release therapy is to release the cervical trigger points, improving end ranges and lengthening of muscle. MDT helps draw toxins out of the muscles and to the superficial veins to be removed by the body. This leads to decreased pain and tension in the tissues. The ultimate goal is to achieve pain free end ranges and flexibility of muscle in nonspecific neck pain patients.

Being tested
Myofascial Decompression Therapy, positional Release Therapy
Keywords
non-specific neck pain, myofascial decompression therapy, positional release therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myofascial Decompression TherapyOther

    Group A will be given myofascial decompression therapy.15 minute's moist heat will be given first. Patient was lied prone on couch with their upper torso unclothed, covered with massage oil than placed cup on skin and suction will created by pump. Than drawn over skin along the spine from cervical to thoracic up to lateral border maintain the suction within skin throughout the procedure. The cup massage will conducted for approximately 10 minutes. Patients were informed that the treatment area may become patchy and there are chances of ecchymosis on the same area.

  • positional Release TherapyOther

    Group B will be given Positional Release technique (PRT) after application of moist heat pack for 15 minute. The subjects received PRT will be in supine lying with the therapist sitting on the affected side, tender points were located along with the upper fibers of trapezius muscle. The subject's head was laterally flexed towards the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 90 degree and adds slight flexion or extension to fine-tune. The ideal position of comfort achieved was held for a period of 90 sec and followed by passive return of body part to an anatomically neutral position continued for 5 minutes. Treatment duration was 3 sessions per week for 4 weeks.

Study groups in NCT05947214
Study groupRoleWhat they receive
Myofascial Decompression TherapyExperimental15 minute's moist heat will be given first. Patient was lied prone on couch with their upper torso unclothed, covered with massage oil than placed cup on skin and suction will created in cups by pump.
Receives: Other: Myofascial Decompression Therapy
Positional Release techniqueExperimentalPositional Release technique (PRT) is apply after application of moist heat pack for 15 minute. The subjects received PRT will be in supine lying with the therapist sitting on the affected side, tender points were located along with the upper fibers of trapezius muscle. The subject's head was laterally flexed towards the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 900 and adds slight flexion or extension to fine-tune.
Receives: Other: positional Release Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Rating Scale (NPRS)

    Numerical Rating Scale (NPRS) Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)

    Measured: 6th week

  2. Neck Disability Index (NDI)

    The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain. Points summed to a total score The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.,0 points or 0% means : no activity limitations .50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. For patients' understanding, the URDU version is used. A clinically important change was calculated as 5 points, with a sensitivity of 0.78 and a specificity of 0.80

    Measured: 6th week

Secondary outcomes (4)
  1. ROM cervical spine (flexion)

    The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor for measuring range of cervical flexion

    Measured: 6th week

  2. ROM cervical spine (extension)

    The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck, for measuring the cervical extension ROM.

    Measured: 6th week

  3. ROM cervical spine (side flexion)

    The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for side flexion

    Measured: 6th week

  4. . ROM cervical spine (Rotation)

    The patient is seated with upper back supported with a chair the center of the goniometer is placed Over center of cranial aspect of head, proximal arm is placed Parallel to imaginary line between the two acromial processes and distal arm With the tip of the nose. If using the tongue depressor, parallel to the longitudinal axis of tongue depressor for cervical rotation ROM.

    Measured: 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start3 Mar 2023
  3. Primary completion28 Sep 2023
  4. Study completion4 Oct 2023

Resources

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
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947214
Sponsor's protocol ID
REC/RCR & AHS/23/0126
Status last verified
Nov 2023
First submitted
14 Jun 2023
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ezzati K, Ravarian B, Saberi A, Salari A, Reyhanian Z, Khakpour M, Yousefzadeh Chabok S. Prevalence of Cervical Myofascial Pain Syndrome and its Correlation with the Severity of Pain and Disability in Patients with Chronic Non-specific Neck Pain. Arch Bone Jt Surg. 2021 Mar;9(2):230-234. doi: 10.22038/abjs.2020.48697.2415.

    PubMed 34026942
  • Rodriguez-Huguet M, Vinolo-Gil MJ, Gongora-Rodriguez J. Dry Needling in Physical Therapy Treatment of Chronic Neck Pain: Systematic Review. J Clin Med. 2022 Apr 23;11(9):2370. doi: 10.3390/jcm11092370.

    PubMed 35566496
  • Anwar S, Arsalan A, Zafar H, Ahmad A, Hanif A. Effects of breathing reeducation on cervical and pulmonary outcomes in patients with non specific chronic neck pain: A double blind randomized controlled trial. PLoS One. 2022 Aug 25;17(8):e0273471. doi: 10.1371/journal.pone.0273471. eCollection 2022.

    PubMed 36006997
  • Moustafa IM, Shousha TM, Walton LM, Raigangar V, Harrison DE. Reduction of Thoracic Hyper-Kyphosis Improves Short and Long Term Outcomes in Patients with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Clin Med. 2022 Oct 13;11(20):6028. doi: 10.3390/jcm11206028.

    PubMed 36294349
  • Peterson G, Peolsson A. Efficacy of Neck-Specific Exercise With Internet Support Versus Neck-Specific Exercise at a Physiotherapy Clinic in Chronic Whiplash-Associated Disorders: Multicenter Randomized Controlled Noninferiority Trial. J Med Internet Res. 2023 Jun 20;25:e43888. doi: 10.2196/43888.

    PubMed 37338972
  • Spellman J, Eldredge R, Nelson M, Ostrowski J, Concannon J. Is Myofascial Decompression Effective at Increasing Hamstring Flexibility in the Athletic Population? A Critically Appraised Topic. J Sport Rehabil. 2022 Aug 8;31(8):1100-1104. doi: 10.1123/jsr.2022-0013. Print 2022 Nov 1.

    PubMed 35940580
  • Parkinson SD, Zanotto GM, Maldonado MD, King MR, Haussler KK. The Effect of Capacitive-Resistive Electrical Therapy on Neck Pain and Dysfunction in Horses. J Equine Vet Sci. 2022 Oct;117:104091. doi: 10.1016/j.jevs.2022.104091. Epub 2022 Jul 29.

    PubMed 35908601

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial Decompression Therapy and positional Release Therapy in people with Chronic Non-specific 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 5 inclusion and 3 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 13 Nov 2023. 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?

Numerical Rating Scale (NPRS) (time frame: 6th week). 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 NCT05947214, 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 13 Nov 2023.

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