PNF and BFR Affect on Pain, ROM & Functional Outcome in Post-op ACL

NCT ID: NCT06943079

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-11

Study Completion Date

2025-01-10

Brief Summary

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A randomized controlled trial investigated the effects of Hold Relax Technique (HRT) with and without Blood Flow Restriction (BFR) on pain, range of motion (ROM), and functional disability in patients with post-operative ACL rehabilitation. This study includes all types of genders with age limit is 25-45 years. But the aim is to infer the answers to the following questions; Does HRT has better effects than HRT with BFR? How much effect should be noted ? The research will show that if both HRT and HRT with BFR groups had significant pain reduction, the HRT with BFR group demonstrated greater ROM improvement and significant enhancement in functional ability compared to the HRT and control groups.

Detailed Description

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A randomized clinical trial will be conducted under Riphah International University guidelines and nonprobability convenient sampling will be used to collect data from the 48 participants from the Ghurki trust and teaching hospital setting. Participants will go through ACL reconstruction specifically the usage of a hamstring graft. The participants were allocated into two groups by using randomization through computer-generated software A and B. In A group only HRT will be applied to check the effects on pain, ROM, and functional disability. In the B group HRT with BFR will be utilized to note the effects on pain, ROM, and functional disability.

Conditions

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Sports Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups; A for the application of HRT B includes HRT and BFR Their effects will be noted on 0 week, 3rd week and 6th week to conclude its result.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A - Hold Relax technique with Blood Flow Restriction technique

Effects of Hold Relax technique with Blood Flow Restriction on functional outcome

Group Type EXPERIMENTAL

Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome

Intervention Type DEVICE

Participants are randomly allocated to group A through computerised generated method. The both combine intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant.

B - Hold relax technique without blood Flow Restriction technique

Effect of Hold Relax technique without Blood flow restriction on functional outcomes

Group Type ACTIVE_COMPARATOR

Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes

Intervention Type OTHER

Participants are randomly allocated to group B through computerised generated method. The intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant.

Interventions

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Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome

Participants are randomly allocated to group A through computerised generated method. The both combine intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant.

Intervention Type DEVICE

Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes

Participants are randomly allocated to group B through computerised generated method. The intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant.

Intervention Type OTHER

Other Intervention Names

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Hold Relax teachnique Blood Flow Restriction technique Hold Relax technique

Eligibility Criteria

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Inclusion Criteria

* Age group 25-45 years.
* Both gender male and female.
* Patient underwent arthroscopic ACL repair procedure.
* Patients in 6 weeks of rehabilitation phase.
* Grafts of hamstring muscle were used in repair.
* Max range achieved after post-op day 1.
* Low- moderate pain intensity.

Exclusion Criteria

* Any form of bone carcinoma.
* Any Post-OP active infectionous Patients.
* Any circulatory effects.
* DVT and pulmonary embolism.
* Loose Implant placement.
* Non co-operative Patient.
* Hyperasthetic Patient.
* Polytraumatic Post-OP Patient.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Humera Mubashar Senior Lecturer, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Other Identifiers

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REC/RCR & AHS/24/0120

Identifier Type: -

Identifier Source: org_study_id

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