NCT06197971

Brief Summary

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Instrument Assisted Soft Tissue Mobilization. Group B will receive Therapeutic Cupping.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

December 26, 2023

Last Update Submit

January 28, 2024

Conditions

FlexibilityHamstring TightnessInstrument Assisted Soft Tissue MobilizationRange of Motion

Keywords

FlexibilityHamstring TightnessInstrument Assisted Soft Tissue MobilizationCupping TechniqueFootball Players

Outcome Measures

Primary Outcomes (3)

  • Hamstring pain

    Patient level of pain will be assessed by using Numerical Rating Scale (NRS) ranging from 0 to 10

    pre and 6 weeks post interventional

  • Range of motion

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

    pre and 6 weeks post interventional

  • Flexibility

    The sit and reach test will be used to assess the flexibility of the hamstring muscles.

    pre and 6 weeks post interventional

Study Arms (2)

Instrument Assisted Soft Tissue Mobilization

OTHER

The therapist will assess the hamstrings to identify areas of restriction or dysfunction. They will use the Graston Technique instruments to apply strokes and movements along the length of the muscle fibers. Sweeping strokes, cross-fiber friction, and circular motions patterns will be applied. The duration of the IASTM treatment will be 15-30 minutes.

Other: Instrument Assisted Soft Tissue Mobilization

Therapeutic Cupping Technique

OTHER

After thorough assessment of the Hamstring area, a thin layer of lubricant will be applied on the area about to be cupped. Stationary cupping technique will be used for a duration of 5-15 minutes with multiple Silicone Cups applied on the Hamstrings. For cupping the hamstrings, cups with a diameter of around 1.5 to 2.5 inches (3.8 to 6.4 cm) will be suitable considering the large area of treatment

Other: Therapeutic Cupping Technique

Interventions

Instrument Assisted Soft Tissue MobilizationOTHER

Graston Technique instruments to apply strokes and movements along the length of the muscle fibers. Sweeping strokes, cross-fiber friction, and circular motions patterns will be applied on hamstring muscles.

Instrument Assisted Soft Tissue Mobilization
Therapeutic Cupping TechniqueOTHER

Stationary cupping technique will be used for a duration of 5-15 minutes with multiple Silicone Cups applied on the Hamstrings.

Therapeutic Cupping Technique

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipant should be a male football player.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age (18-25),Male Gender Only,
  • Football Players, Bilateral Hamstring Tightness,
  • Previous hamstring injury in the last 6 months,
  • Positive SLR test,
  • Positive Passive/Active Knee Extension test

You may not qualify if:

  • Malignancy of lower limb,
  • History of Lower Limb fracture in the last 6 months,
  • Post-surgical condition from past 6 months,
  • Neurological Conditions such as SLE, Herpes zoster, parkinsonism, Shingles disease, Musculoskeletal disorders like adductor tendinopathy, low back pain, knee injuries, hip injuries,
  • Skin Allergies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan sports board

Lahore, Punjab Province, 53700, Pakistan

RECRUITING

Related Publications (9)

  • Bridgett R, Klose P, Duffield R, Mydock S, Lauche R. Effects of Cupping Therapy in Amateur and Professional Athletes: Systematic Review of Randomized Controlled Trials. J Altern Complement Med. 2018 Mar;24(3):208-219. doi: 10.1089/acm.2017.0191. Epub 2017 Nov 29.

    PMID: 29185802BACKGROUND

  • Cheatham SW, Baker R, Kreiswirth E. INSTRUMENT ASSISTED SOFT-TISSUE MOBILIZATION: A COMMENTARY ON CLINICAL PRACTICE GUIDELINES FOR REHABILITATION PROFESSIONALS. Int J Sports Phys Ther. 2019 Jul;14(4):670-682.

    PMID: 31440416BACKGROUND

  • Ikeda N, Otsuka S, Kawanishi Y, Kawakami Y. Effects of Instrument-assisted Soft Tissue Mobilization on Musculoskeletal Properties. Med Sci Sports Exerc. 2019 Oct;51(10):2166-2172. doi: 10.1249/MSS.0000000000002035.

    PMID: 31083046BACKGROUND

  • Kim J, Sung DJ, Lee J. Therapeutic effectiveness of instrument-assisted soft tissue mobilization for soft tissue injury: mechanisms and practical application. J Exerc Rehabil. 2017 Feb 28;13(1):12-22. doi: 10.12965/jer.1732824.412. eCollection 2017 Feb.

    PMID: 28349028BACKGROUND

  • Baker RT, Nasypany A, Seegmiller JG, Baker JG. Instrument-assisted soft tissue mobilization treatment for tissue extensibility dysfunction. International Journal of Athletic Therapy and Training. 2013 Sep 1;18(5):16-21.

    BACKGROUND

  • Cheatham SW, Lee M, Cain M, Baker R. The efficacy of instrument assisted soft tissue mobilization: a systematic review. J Can Chiropr Assoc. 2016 Sep;60(3):200-211.

    PMID: 27713575BACKGROUND

  • Thomas K. Blood Flow Restriction and Other Innovations in Musculoskeletal Rehabilitation. In: Endurance Sports Medicine: A Clinical Guide. Cham: Springer International Publishing; 2023. p. 237-266

    BACKGROUND

  • Hartnett DA. Gua sha therapy in the management of musculoskeletal pathology: a narrative review. Phys Ther Rev. 2022;27(3):169-175.

    BACKGROUND

  • 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

Study Officials

  • Sikander Naseer, DPT

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Ghafoor, M Phil

CONTACT

0334-4292887imran.ghafoor@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor who will take the readings is blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trail
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

October 20, 2023

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)