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Low Back PainNCT05978765

Effect of Dynamic Cupping & Myofascial Release on Pain, ROM and Performance in Athletes With Low Back Pain

A study testing Dry Cupping and Myofascial Release in people with Low Back Pain and Myofascial 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

Data will be collected at Pakistan Sports Board Lahore. Study design will be Randomized Clinical Trial. Sample size is 28. Population will be divided into two Groups by Convinient Sampling Technique. Group A willl be Treated with Dynamic Cupping And Group B will be Treated with Soft Tissue Myofascial Release. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Low Back Pain, Myofascial Pain, Back Strain
What is being tested?
Dry Cupping and Myofascial Release
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 sitePakistan
Study dates
2 Jan 2023to 30 Jun 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 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both male and female
  • 18-35years(1)
  • low Backpain
  • NPRS (3 to 10 cut of value)
  • Must be a Sports related persons.

Who cannot join

  • Systemic Illness. (Diabetes mellitus,Tuberculosis, Arthritis, Scoliosis)
  • History of Fracture in last 6 months
  • Stayed out of Sports from last 6 months
  • History of Disc Buldge and another structural problem.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Lahore, Punjab Province, 54770

Other trials in Pakistan

About this study

Official title: Effect of Dynamic Cupping Versus Myofascial Release on Pain, Range of Motion and Functional Performance in Athletes With Non-specific Low Back Pain

Data will be collected at Pakistan Sports Board Lahore. Study design will be Randomized Clinical Trial. Sample size is 28. Population will be divided into two Groups by Convinient Sampling Technique. Group A willl be Treated with Dynamic Cupping And Group B will be Treated with Soft Tissue Myofascial Release. Inclinometer, Back Pain Functional Scale, Functional Mobility Scale and Numerc Pain Rating Scale will be used to generate the outcomes of study.

Read the detailed description

The objective of this study is to compare the Effects Of Dynamic Cupping Versus Myofascial Release on Pain, Range of motion and Function in athletes with non-specific low back pain.

Tools to be used in this study will be :

Inclinometer: An inclinometer is a sensor used to measure the magnitude of the inclination angle or deformation of any structure

. Back Pain Functional Scale: a subjective scale used to measure the patient's physical function after low back pain.

FMS: The Functional Mobility Scale (FMS) has been constructed to classify functional mobility.

Numeric PAIN Ratig Scale: The numeric rating scale (NRS) is a pain the screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

The study will be collected from Sports related persons at Pakistan Sports Board Lahore. First, a consent form will be filled the person and then the data will be recorded through our questionaire on day 1 and then after 6 weeks of treatment. Group A will be treated with Dynamic Cupping and Group B will be treated with Myofascial release. Group A: will be an interventional group and it will be treated by using dynamic cupping. Heating pad will be applied for 10 minutes as a base treatment then olive oil or petroleum jelly will be applied and cup will be placed,a vacuum will be created by using a vacuum pump then the cup will be moved to and fro or in figure of 8 for 5 minutes. Group B : Will be a control group and it will be treated by soft tissue myofascial release. Heating pad will be applied for 10 minutes as a base treatment, and petroleum jelly will be applied to the area followed by soft tissue myofascial release technique for 5 minutes either crisscross, along the fiber or in Figure of 8.

Being tested
Dry Cupping, Myofascial Release
Keywords
Athletic Performance, Low back pain, Myofascial release, Range of motion
Medical subject headings
Low Back Pain

What participants receive

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

  • Dry CuppingDevice

    treated by using dynamic cupping. Heating pad will be applied for 10 minutes as a base treatment then olive oil or petroleum jelly will be applied and a cup will be placed, a vacuum will be created by using vacuum pump then the cup will be moved to and fro or in figure of 8 for 5 minutes.

  • Myofascial ReleaseOther

    e treated by soft tissue myofascial release. Heating pad will be applied for 10 minutes as a base treatment,petroleum jelly will be applied to the area follow by soft tissue myofascial release technique for 5 minutes either criss cross, along the fiber or in figure of 8

Study groups in NCT05978765
Study groupRoleWhat they receive
InclinometerExperimentalInclinometer : An inclinometer is a sensor used to measure the magnitude of the inclination angle or deformation of any structure
Receives: Device: Dry Cupping; Other: Myofascial Release
Back Pain Functional ScaleExperimentala subjective scale used to measure the patient's physical function after low back pain
Receives: Device: Dry Cupping; Other: Myofascial Release
Functional Mobility ScaleExperimentalhas been constructed to classify functional mobility
Receives: Device: Dry Cupping; Other: Myofascial Release
Numeric Pain Rating ScaleExperimentalA pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable
Receives: Device: Dry Cupping; Other: Myofascial Release

What is being measured

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

  1. Inclinometer

    An inclinometer is a sensor used to measure the magnitude of the inclination angle or deformation of any structure

    Measured: 10 months

  2. Back Pain Functional Scale

    a subjective scale used to measure the patient's physical function after low back pain

    Measured: 10 Months

  3. Functional Mobility Scale

    The Functional Mobility Scale (FMS) has been constructed to classify functional mobility

    Measured: 10 months

  4. Numeric Pain Rating Scale

    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable(

    Measured: 10 months

Timeline

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

  1. First posted7 Aug 2023
  2. Study start2 Jan 2023
  3. Primary completion20 Jun 2023
  4. Study completion30 Jun 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
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05978765
Sponsor's protocol ID
REC/RCR&AHS/23/0414 UMER
Status last verified
Aug 2023
First submitted
31 Jul 2023
Last updated
22 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lohr C, Medina-Porqueres I. Immediate effects of myofascial release on neuromechanical characteristics in female and male patients with low back pain and healthy controls as assessed by tensiomyography. A controlled matched-pair study. Clin Biomech (Bristol). 2021 Apr;84:105351. doi: 10.1016/j.clinbiomech.2021.105351. Epub 2021 Apr 5.

    PubMed 33848704
  • Khan ZK, Ahmed SI, Baig AAM, Farooqui WA. Effect of post-isometric relaxation versus myofascial release therapy on pain, functional disability, rom and qol in the management of non-specific neck pain: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Jun 13;23(1):567. doi: 10.1186/s12891-022-05516-1.

    PubMed 35698187
  • Quinones S, Konschake M, Aguilar LL, Simon C, Aragones P, Hernandez LM, Abramovic A, Tubbs RS, Bouzada J, Valderrama-Canales FJ, Vazquez T, Sanudo J. Clinical anatomy of the lumbar sinuvertebral nerve with regard to discogenic low back pain and review of literature. Eur Spine J. 2021 Oct;30(10):2999-3008. doi: 10.1007/s00586-021-06886-1. Epub 2021 May 30.

    PubMed 34052894
  • Frost BA, Camarero-Espinosa S, Foster EJ. Materials for the Spine: Anatomy, Problems, and Solutions. Materials (Basel). 2019 Jan 14;12(2):253. doi: 10.3390/ma12020253.

    PubMed 30646556
  • Ughreja RA, Venkatesan P, Balebail Gopalakrishna D, Singh YP. Effectiveness of myofascial release on pain, sleep, and quality of life in patients with fibromyalgia syndrome: A systematic review. Complement Ther Clin Pract. 2021 Nov;45:101477. doi: 10.1016/j.ctcp.2021.101477. Epub 2021 Aug 27.

    PubMed 34507243
  • Salemi MM, Gomes VMDSA, Bezerra LMR, Melo TMS, Alencar GG, Montenegro IHPM, Calado APM, Montenegro EJN, Siqueira GR. Effect of Dry Cupping Therapy on Pain and Functional Disability in Persistent Non-Specific Low Back Pain: A Randomized Controlled Clinical Trial. J Acupunct Meridian Stud. 2021 Dec 31;14(6):219-230. doi: 10.51507/j.jams.2021.14.6.219.

    PubMed 35770601
  • Skelly AC, Chou R, Dettori JR, Turner JA, Friedly JL, Rundell SD, Fu R, Brodt ED, Wasson N, Kantner S, Ferguson AJR. Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Apr. Report No.: 20-EHC009. Available from http://www.ncbi.nlm.nih.gov/books/NBK556229/

    PubMed 32338846
  • Wang YT, Qi Y, Tang FY, Li FM, Li QH, Xu CP, Xie GP, Sun HT. The effect of cupping therapy for low back pain: A meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1187-1195. doi: 10.3233/BMR-169736.

    PubMed 28946531
  • Moura CC, Chaves ECL, Cardoso ACLR, Nogueira DA, Correa HP, Chianca TCM. Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3094. doi: 10.1590/1518-8345.2888.3094.

    PubMed 30462793
  • Silva HJA, Saragiotto BT, Silva RS, Lins CAA, de Souza MC. Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study. BMJ Open. 2019 Dec 22;9(12):e032416. doi: 10.1136/bmjopen-2019-032416.

    PubMed 31871257
  • Rahyussalim AJ, Zufar MLL, Kurniawati T. Significance of the Association between Disc Degeneration Changes on Imaging and Low Back Pain: A Review Article. Asian Spine J. 2020 Apr;14(2):245-257. doi: 10.31616/asj.2019.0046. Epub 2019 Nov 5.

    PubMed 31679325
  • Oiestad BE, Hilde G, Tveter AT, Peat GG, Thomas MJ, Dunn KM, Grotle M. Risk factors for episodes of back pain in emerging adults. A systematic review. Eur J Pain. 2020 Jan;24(1):19-38. doi: 10.1002/ejp.1474. Epub 2019 Sep 3.

    PubMed 31433541
  • Sassack B, Carrier JD. Anatomy, Back, Lumbar Spine. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557616/

    PubMed 32491548
  • Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.

    PubMed 30252425
  • Brandl A, Egner C, Schleip R. Reply to Kudus, A.L. Comment on "Brandl et al. Immediate Effects of Myofascial Release on the Thoracolumbar Fascia and Osteopathic Treatment for Acute Low Back Pain on Spine Shape Parameters: A Randomized, Placebo-Controlled Trial. Life 2021, 11, 845". Life (Basel). 2022 Jun 10;12(6):868. doi: 10.3390/life12060868.

    PubMed 35743899

Questions about this trial

What is this clinical trial studying?

A study testing Dry Cupping and Myofascial Release in people with Low Back Pain and Myofascial 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 4 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 22 Aug 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?

Inclinometer (time frame: 10 months). The study lists 4 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 NCT05978765, which also lists 21 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 22 Aug 2023.

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