NCT05978765

Brief 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. Inclinometer, Back Pain Functional Scale, Functional Mobility Scale and Numerc Pain Rating Scale will be used to generate the outcomes of study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable low-back-pain

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

January 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

July 31, 2023

Last Update Submit

August 18, 2023

Conditions

Keywords

Athletic PerformanceLow back painMyofascial releaseRange of motion

Outcome Measures

Primary Outcomes (4)

  • Inclinometer

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

    10 months

  • Back Pain Functional Scale

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

    10 Months

  • Functional Mobility Scale

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

    10 months

  • 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(

    10 months

Study Arms (4)

Inclinometer

EXPERIMENTAL

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

Device: Dry CuppingOther: Myofascial Release

Back Pain Functional Scale

EXPERIMENTAL

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

Device: Dry CuppingOther: Myofascial Release

Functional Mobility Scale

EXPERIMENTAL

has been constructed to classify functional mobility

Device: Dry CuppingOther: Myofascial Release

Numeric Pain Rating Scale

EXPERIMENTAL

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

Device: Dry CuppingOther: Myofascial Release

Interventions

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.

Back Pain Functional ScaleFunctional Mobility ScaleInclinometerNumeric Pain Rating Scale

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

Back Pain Functional ScaleFunctional Mobility ScaleInclinometerNumeric Pain Rating Scale

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (21)

  • 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.

    PMID: 33848704BACKGROUND
  • 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.

    PMID: 35698187BACKGROUND
  • 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.

    PMID: 34052894BACKGROUND
  • 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.

    PMID: 30646556BACKGROUND
  • 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.

    PMID: 34507243BACKGROUND
  • 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.

    PMID: 35770601BACKGROUND
  • 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/

    PMID: 32338846BACKGROUND
  • 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.

    PMID: 28946531BACKGROUND
  • 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.

    PMID: 30462793BACKGROUND
  • 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.

    PMID: 31871257BACKGROUND
  • 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.

    PMID: 31679325BACKGROUND
  • 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.

    PMID: 31433541BACKGROUND
  • Sassack B, Carrier JD. Anatomy, Back, Lumbar Spine. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557616/

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

    PMID: 30252425BACKGROUND
  • 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.

    PMID: 35743899BACKGROUND
  • Warren AJ, LaCross Z, Volberding JL, O'Brien MS. ACUTE OUTCOMES OF MYOFASCIAL DECOMPRESSION (CUPPING THERAPY) COMPARED TO SELF-MYOFASCIAL RELEASE ON HAMSTRING PATHOLOGY AFTER A SINGLE TREATMENT. Int J Sports Phys Ther. 2020 Aug;15(4):579-592.

    PMID: 33354391BACKGROUND
  • Wood S, Fryer G, Tan LLF, Cleary C. Dry cupping for musculoskeletal pain and range of motion: A systematic review and meta-analysis. J Bodyw Mov Ther. 2020 Oct;24(4):503-518. doi: 10.1016/j.jbmt.2020.06.024. Epub 2020 Jul 30.

    PMID: 33218554BACKGROUND
  • Kameda M, Tanimae H. Effectiveness of active soft tissue release and trigger point block for the diagnosis and treatment of low back and leg pain of predominantly gluteus medius origin: a report of 115 cases. J Phys Ther Sci. 2019 Feb;31(2):141-148. doi: 10.1589/jpts.31.141. Epub 2019 Feb 7.

    PMID: 30858653BACKGROUND
  • Wu Z, Wang Y, Ye X, Chen Z, Zhou R, Ye Z, Huang J, Zhu Y, Chen G, Xu X. Myofascial Release for Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 Jul 28;8:697986. doi: 10.3389/fmed.2021.697986. eCollection 2021.

    PMID: 34395477BACKGROUND
  • Chen Z, Wu J, Wang X, Wu J, Ren Z. The effects of myofascial release technique for patients with low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102737. doi: 10.1016/j.ctim.2021.102737. Epub 2021 May 10.

    PMID: 33984499BACKGROUND
  • Liu YW, Su YL, Chang CL, Tsai MY. Cupping Therapy as an Adjunctive Therapy for Side Effects of Colorectal Cancer Treatment: A Prospective Observational Study. J Chiropr Med. 2022 Dec;21(4):280-287. doi: 10.1016/j.jcm.2022.02.011. Epub 2022 May 21.

    PMID: 36420364BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Aamir Gul Memon, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

January 2, 2023

Primary Completion

June 20, 2023

Study Completion

June 30, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations