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NCT Number: NCT06943079

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

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.

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Key information

Conditions

Sports Physical Therapy

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Hold Relax teachnique, 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.

Other names: Hold Relax technique

Primary outcomes

  1. 1- BFR Cuff

    Time frame: 6 weeks

    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)

  2. 2- UNIVERSAL GONIOMETER

    Time frame: 6 weeks

    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)

  3. 3- NUMERIC PAIN RATING SCALE (NPRS)

    Time frame: 6 weeks

    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)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Hold-relax Technique With or Without Blood Flow Restriction on Pain, Range of Motion and Functional Disability in Patients With Post Operative ACL Rehabilitation.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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