FlexibilityNCT06197971
Instrument Assisted Soft Tissue Mobilization vs Therapeutic Cupping on Hamstring Tightness Among Football Players
A study testing Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping Technique in people with Flexibility and Hamstring Tightness, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Flexibility, Hamstring Tightness, Instrument Assisted Soft Tissue Mobilization
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 20 Feb 2024
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan sports board
Lahore, Punjab Province, 53700
Moiz Kamal, bachelors, 0306-5595979, mkh.physio1@gmail.com
Sikander Naseer, DPT, +92-3370463069, sikandernaseer3@gmail.com
About this study
Official title: Comparative Effects of Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping on Hamstring Tightness Among Football Players
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.
Read the detailed description
The objective of the study is to determine the effects of Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping on Hamstring tightness among football players. 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. Players will be assessed by Numeric pain rating scale, Universal Goniometer and Sit \& Reach Test after the completion of treatment at 6 weeks.
The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.
- Conditions
- Flexibility, Hamstring Tightness, Instrument Assisted Soft Tissue Mobilization, Range of Motion
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Therapeutic Cupping Technique
- Keywords
- Flexibility, Hamstring Tightness, Instrument Assisted Soft Tissue Mobilization, Cupping Technique, Football Players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Therapeutic Cupping TechniqueOther
Stationary cupping technique will be used for a duration of 5-15 minutes with multiple Silicone Cups applied on the Hamstrings.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Therapeutic Cupping Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring pain
Patient level of pain will be assessed by using Numerical Rating Scale (NRS) ranging from 0 to 10
Measured: pre and 6 weeks post interventional
Range of motion
A goniometer is an instrument that measures the available range of motion at a joint.
Measured: pre and 6 weeks post interventional
Flexibility
The sit and reach test will be used to assess the flexibility of the hamstring muscles.
Measured: pre and 6 weeks post interventional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start20 Oct 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FlexibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trail
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sikander Naseer, DPT, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197971
- Sponsor's protocol ID
- REC/RCR&AHS/23/0461
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29185802Cheatham 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.
PubMed 31440416Ikeda 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.
PubMed 31083046Kim 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.
PubMed 28349028Baker 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.
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.
PubMed 27713575Thomas 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
Hartnett DA. Gua sha therapy in the management of musculoskeletal pathology: a narrative review. Phys Ther Rev. 2022;27(3):169-175.
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.
PubMed 33354391
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping on Hamstring Tightness Among Football Players
- ClinicalTrials.gov ID
- NCT06197971
- Acronym / sponsor ID
- REC/RCR&AHS/23/0461
- Conditions
- Flexibility, Hamstring Tightness, Instrument Assisted Soft Tissue Mobilization, Range of Motion
- Keywords
- Flexibility, Hamstring Tightness, Instrument Assisted Soft Tissue Mobilization, Cupping Technique, Football Players
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the study is to determine the effects of Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping on Hamstring tightness among football players. 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. Players will be assessed by Numeric pain rating scale, Universal Goniometer and Sit \& Reach Test after the completion of treatment at 6 weeks.
The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trail
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Other | Other: Instrument Assisted Soft Tissue MobilizationThe 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. |
| Therapeutic Cupping Technique | Other | Other: Therapeutic Cupping TechniqueAfter 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationGraston 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. | Other | Instrument Assisted Soft Tissue Mobilization |
| Therapeutic Cupping TechniqueStationary cupping technique will be used for a duration of 5-15 minutes with multiple Silicone Cups applied on the Hamstrings. | Other | Therapeutic Cupping Technique |
Primary outcome
Hamstring pain
Time frame: pre and 6 weeks post interventional
Patient level of pain will be assessed by using Numerical Rating Scale (NRS) ranging from 0 to 10
Range of motion
Time frame: pre and 6 weeks post interventional
A goniometer is an instrument that measures the available range of motion at a joint.
Flexibility
Time frame: pre and 6 weeks post interventional
The sit and reach test will be used to assess the flexibility of the hamstring muscles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 29185802Bridgett 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.
- Background: PubMed 31440416Cheatham 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.
- Background: PubMed 31083046Ikeda 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.
- Background: PubMed 28349028Kim 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.
- BackgroundBaker 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: PubMed 27713575Cheatham 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.
- BackgroundThomas 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
- BackgroundHartnett DA. Gua sha therapy in the management of musculoskeletal pathology: a narrative review. Phys Ther Rev. 2022;27(3):169-175.
- Background: PubMed 33354391Warren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sikander Naseer, DPT principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping Technique in people with Flexibility and Hamstring Tightness, 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 5 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Ghafoor, M Phil (0334-4292887, imran.ghafoor@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring pain (time frame: pre and 6 weeks post interventional). 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 NCT06197971, which also lists 9 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 30 Jan 2024.