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Neck PainNCT05392465

Effects of Holistic Spinal Fascial Mobilization in Neck Pain

A study testing Fascial mobilization group and Conventional physical therapy in people with 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

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… Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Neck Pain
What is being tested?
Fascial mobilization group and Conventional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
30 May 2022to 30 Jan 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Bhawal Victoria Hospital, Bhawalpur

    Bahawalpur, Punjab Province

Other trials in Pakistan

About this study

Official title: Effects of Holistic Spinal Fascial Mobilization on Pain, Range of Motion and Function in Patients With Chronic Neck Pain

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.

Read the detailed description

Chronic neck pain is one of the most common musculoskeletal disorders among the general population. Like a muscular spasm of the neck that can cause neck pain, fascial adhesions are also a common cause of neck pain. Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts, and also resists tissue tensile load. There is huge literature regarding the management of neck pain and yet after decades of research, there are gaps in treatment options. In the modern age of health care, it is a common goal of every health care to make patients self-sufficient as early as possible. The self-care models have tremendous advantages. The current study aims to determine the effects of holistic spinal fascial mobilization on pain, range of motion, and function in patients with chronic neck pain. All treatment methods were employed to see if they improve the ranges accompanying pain and disability.

Conditions
Neck Pain
Being tested
Fascial mobilization group, Conventional physical therapy
Keywords
Fascia, Range of motion, Mobilization
Medical subject headings
Neck Pain

What participants receive

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

  • 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.

  • 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.

Study groups in NCT05392465
Study groupRoleWhat they receive
Group AExperimentalbaseline physical therapy treatment along with facial mobilization
Receives: Other: Fascial mobilization group
Group BOtherbaseline (Conventional) physical therapy treatment
Receives: Other: Conventional physical therapy

What is being measured

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

  1. 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

    Measured: 3rd day

  2. 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.

    Measured: 3rd day

  3. Goniometric measurement of Neck ROM

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

    Measured: 3rd day

Timeline

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

  1. First posted26 May 2022
  2. Study start30 May 2022
  3. Primary completion30 Dec 2022
  4. Study completion30 Jan 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
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392465
Sponsor's protocol ID
REC/RCR & AHS/22/0144 Nimra
Status last verified
Jan 2023
First submitted
23 May 2022
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20466711

  • 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.

    PubMed 16323384

  • 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.

  • 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.

    PubMed 19166469

  • 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.

  • 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.

    PubMed 28956477

  • 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.

    PubMed 32317109

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

  • 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.

    PubMed 19524848

  • 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.

    PubMed 21589701

Questions about this trial

What is this clinical trial studying?

A study testing Fascial mobilization group and Conventional physical therapy in people with 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 1 Feb 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?

NPRS (time frame: 3rd day). 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 NCT05392465, which also lists 10 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 1 Feb 2023.

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