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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06943079
Enrollment
48
Registered
2025-04-24
Start date
2024-02-11
Completion date
2025-01-10
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sports Physical Therapy

Keywords

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

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.

Detailed description

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.

Interventions

DEVICEEffect 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.

OTHEREffect 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.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
3- NUMERIC PAIN RATING SCALE (NPRS)6 weeksThe 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)
1- BFR Cuff6 weeksBFR 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- UNIVERSAL GONIOMETER6 weeksThe 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)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026