NCT05947214

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 14, 2023

Last Update Submit

November 10, 2023

Conditions

Keywords

non-specific neck painmyofascial decompression therapypositional release therapy

Outcome Measures

Primary Outcomes (2)

  • 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)

    6th week

  • 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

    6th week

Secondary Outcomes (4)

  • ROM cervical spine (flexion)

    6th week

  • ROM cervical spine (extension)

    6th week

  • ROM cervical spine (side flexion)

    6th week

  • . ROM cervical spine (Rotation)

    6th week

Study Arms (2)

Myofascial Decompression Therapy

EXPERIMENTAL

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 in cups by pump.

Other: Myofascial Decompression Therapy

Positional Release technique

EXPERIMENTAL

Positional 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.

Other: positional Release Therapy

Interventions

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.

Myofascial Decompression Therapy

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.

Positional Release technique

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 34026942BACKGROUND
  • 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.

    PMID: 35566496BACKGROUND
  • 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.

    PMID: 36006997BACKGROUND
  • 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.

    PMID: 36294349BACKGROUND
  • 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.

    PMID: 37338972BACKGROUND
  • 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.

    PMID: 35940580BACKGROUND
  • 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.

    PMID: 35908601BACKGROUND

Study Officials

  • Sana Hafeez, PhD*

    Riphah International University Lahore Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 17, 2023

Study Start

March 3, 2023

Primary Completion

September 28, 2023

Study Completion

October 4, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations