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

NCT06943079 | Completed

• 1 other identifier: REC/RCR & AHS/24/0120
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sports Physical Therapy

Keywords

ACL reconstruction; Hamstring graft; Hold relax technique; Blood flow restriction; Knee joint

Outcome Measures

Primary Outcomes (3)

• 1- BFR Cuff

  BFR requires a tourniquet to be placed on a limb. The cuff needs to be tightened to a specific pressure that occludes venous flow while still allowing arterial flow whilst exercises are being performed. Simple pieces of equipment such as surgical tubing or elastic straps have been used in gym settings to achieve this result. These are not advisable as you are unable to monitor the amount of blood flow occlusion. A thin diameter may also cause too much local pressure and result in tissue damage.(29)

  6 weeks

• 2- UNIVERSAL GONIOMETER

  The measurement of joint range of motion (ROM), also referred to as goniometry, is a crucial physical therapy practice.(30) Goniometry, the measuring of joint angles, is a frequently used assessment tool in the tracking of rehabilitation interventions as well as issues with the musculoskeletal system. It is generally performed with a universal goniometer (UG).(31) Inter-tester reliability for universal goniometers is mediocre.(32)

  6 weeks

• 3- NUMERIC PAIN RATING SCALE (NPRS)

  The Numeric Pain Rating Scale (NRS-11) is an eleven-point rating system with a score of 0 representing no pain at all and a score of 10 representing the greatest agony the patient has ever had. In this context, the NPRS-11 pain severity score of "4" is usually given particular weight, indicating that it may serve as a threshold value for pain severity in clinical practice.(33) Its dependability coefficient is high (0.95-0.96).(34)

  6 weeks

Study Arms (2)

A - Hold Relax technique with Blood Flow Restriction technique

EXPERIMENTAL

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

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

B - Hold relax technique without blood Flow Restriction technique

ACTIVE COMPARATOR

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

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

Interventions

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

Also known as: Hold Relax teachnique, Blood Flow Restriction technique

A - Hold Relax technique with Blood Flow Restriction technique

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

Also known as: Hold Relax technique

B - Hold relax technique without blood Flow Restriction technique

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

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Study Officials

• Humera Mubashar Senior Lecturer, MS-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: February 11, 2024
• Primary Completion: December 2, 2024
• Study Completion: January 10, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)