NCT05392465

Brief Summary

This study aims to determine the effects of holistic spinal fascial mobilization on pain, range of motion and function in patients with chronic neck pain so that we can have the best treatment option for patients with chronic neck pain, the duration will be 10 months, purposive sampling will be done, subject following eligibility criteria from bahawal Victoria hospital Bahawalpur, were allocated in two groups, a baseline assessment was done, Group A participants were given conventional treatment along with fascial mobilization, Group B participants were given conventional treatment, Numeric pain rating scale(NPRS), Neck Disability Index(NDI) and Goniometry for a range of motion,3 sessions per week were given, data was analyzed by using SPSS version 25.

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 May 2022

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

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

January 31, 2023

Conditions

Neck Pain

Keywords

FasciaRange of motionMobilization

Outcome Measures

Primary Outcomes (3)

  • NPRS

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain

    3rd day

  • NDI

    The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 5.

    3rd day

  • Goniometric measurement of Neck ROM

    A goniometer is an instrument which measures the available range of motion at a joint.

    3rd day

Study Arms (2)

Group A

EXPERIMENTAL

baseline physical therapy treatment along with facial mobilization

Other: Fascial mobilization group

Group B

OTHER

baseline (Conventional) physical therapy treatment

Other: Conventional physical therapy

Interventions

Fascial mobilization groupOTHER

Fascial mobilization+ conventional treatment (3 sessions per week). MFR is thought to work directly on restricted fascia; practitioners use knuckles or elbow to slowly sink into the fascia, and the pressure applied to contact the restricted fascia, apply tension, or stretch the fascia. MFR involves application of gentle stretch the pressure applied is a few grams of force, and the hands tend to follow the direction of fascial restriction, hold the stretch, and allow the fascia to release itself + hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation).A total of 40-45 min session three times a week on alternate days for three weeks.

Group A
Conventional physical therapyOTHER

Conventional Therapy (3 sessions per week). In this treatment group conventional treatment for chronic neck pain will be given which includes hot pack, Neck Isometrics and Neck Stretches. Hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotators).A total of 40-45 min session three times a week on alternate days for three weeks On eligible participants baseline assessment was done,3 session were given per week.

Group B

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders.
  • Age 25-60 years.
  • NPRS \>4
  • Subjects diagnosed with chronic neck pain with minimum 3 months of chronicity
  • Subjects without any other pathology affecting the neck and upper limb.

You may not qualify if:

  • Subjects with a history of Vertebro-Basilar artery insufficiency
  • Any bony, soft tissue, systemic disease, fever, malnutrition or tumor.
  • Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bhawal Victoria Hospital, Bhawalpur

Bahawalpur, Punjab Province, Pakistan

Location

Related Publications (10)

  • McLean SM, May S, Klaber-Moffett J, Sharp DM, Gardiner E. Risk factors for the onset of non-specific neck pain: a systematic review. J Epidemiol Community Health. 2010 Jul;64(7):565-72. doi: 10.1136/jech.2009.090720. Epub 2010 May 12.

    PMID: 20466711BACKGROUND

  • Chiu TT, Hui-Chan CW, Chein G. A randomized clinical trial of TENS and exercise for patients with chronic neck pain. Clin Rehabil. 2005 Dec;19(8):850-60. doi: 10.1191/0269215505cr920oa.

    PMID: 16323384BACKGROUND

  • Bakry HA. The effect of poor posture on the cervical range of motion in young subjects. Egyptian Journal of Physical Therapy. 2021;5(1):5-12.

    BACKGROUND

  • Benjamin M. The fascia of the limbs and back--a review. J Anat. 2009 Jan;214(1):1-18. doi: 10.1111/j.1469-7580.2008.01011.x.

    PMID: 19166469BACKGROUND

  • Hrkal P. Fascia: The Tensional Network of the Human Body: The science and clinical applications in manual and movement therapy. Journal of the Canadian Chiropractic Association. 2015;59(4):417-8.

    BACKGROUND

  • Laimi K, Makila A, Barlund E, Katajapuu N, Oksanen A, Seikkula V, Karppinen J, Saltychev M. Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Clin Rehabil. 2018 Apr;32(4):440-450. doi: 10.1177/0269215517732820. Epub 2017 Sep 28.

    PMID: 28956477BACKGROUND

  • Rodriguez-Huguet M, Rodriguez-Almagro D, Rodriguez-Huguet P, Martin-Valero R, Lomas-Vega R. Treatment of Neck Pain With Myofascial Therapies: A Single Blind Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Feb;43(2):160-170. doi: 10.1016/j.jmpt.2019.12.001. Epub 2020 Apr 18.

    PMID: 32317109BACKGROUND

  • Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.

    BACKGROUND

  • Quere N, Noel E, Lieutaud A, d'Alessio P. Fasciatherapy combined with pulsology touch induces changes in blood turbulence potentially beneficial for vascular endothelium. J Bodyw Mov Ther. 2009 Jul;13(3):239-45. doi: 10.1016/j.jbmt.2008.06.012. Epub 2008 Aug 12.

    PMID: 19524848BACKGROUND

  • Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.

    PMID: 21589701BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil-ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)