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Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.

Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07662850
Enrollment
46
Registered
2026-06-23
Start date
2026-06-12
Completion date
2026-11-20
Last updated
2026-06-29

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

Conditions

ACL Reconstruction

Keywords

Anterior Cruciate Ligament Reconstruction, Blood Flow Restriction Training, Instrument-Assisted Soft Tissue Mobilization, Quadriceps Strength, Range Of Motion, Pain, Kinesiophobia

Brief summary

This randomized clinical trial aims to compare the effects of Blood Flow Restriction Training (BFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) on pain, quadriceps muscle strength, knee range of motion (ROM), and kinesiophobia in patients following anterior cruciate ligament reconstruction (ACLR). ACLR patients commonly experience persistent muscle weakness, limited ROM, pain, and fear of movement, which can delay functional recovery and return to activity. A total of 46 participants (8-16 weeks post-ACLR) will be randomly allocated into two groups: a BFR group and an IASTM group. Both groups will receive interventions twice weekly for 8 weeks alongside standard physiotherapy. The BFR group will perform low-load resistance exercises under controlled vascular occlusion, while the IASTM group will receive soft tissue mobilization using specialized instruments combined with conventional rehabilitation. Outcome measures will include quadriceps strength (handheld dynamometer), pain (Numeric Pain Rating Scale), knee ROM (goniometer), and kinesiophobia (Tampa Scale of Kinesiophobia), assessed at baseline and post-intervention. The study aims to determine which intervention provides superior improvements in physical and psychological outcomes during early rehabilitation after ACL reconstruction.

Detailed description

Anterior cruciate ligament reconstruction (ACLR) is a commonly performed surgical procedure to restore knee stability following ACL injury. Despite surgical success, many patients experience persistent quadriceps weakness, pain, reduced range of motion (ROM), and psychological barriers such as kinesiophobia, which can delay functional recovery and return to activity. Optimizing early rehabilitation strategies is therefore essential to improve both physical and psychological outcomes after ACLR. Blood Flow Restriction Training (BFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) are two emerging rehabilitation techniques increasingly used in musculoskeletal and postoperative care. BFR involves the application of controlled external pressure to partially restrict blood flow during low-load resistance exercise, thereby promoting muscle strength and hypertrophy with minimal mechanical stress. This makes it particularly suitable during early rehabilitation phases when high-load exercises may be contraindicated. IASTM is a manual therapy technique that utilizes specialized instruments to mobilize soft tissues, improve circulation, reduce pain, and enhance tissue extensibility. It is commonly used to address soft tissue restrictions, improve joint mobility, and support functional recovery. Although both interventions have demonstrated beneficial effects independently, there is limited comparative evidence evaluating their relative effectiveness in patients undergoing ACLR. Additionally, most previous studies have focused primarily on physical outcomes such as strength and ROM, with limited attention to psychological factors such as kinesiophobia, which play a critical role in rehabilitation success and return-to-sport readiness. This study is designed as a two-arm parallel-group randomized clinical trial to compare the effects of BFR and IASTM on pain, quadriceps strength, knee ROM, and kinesiophobia in patients following ACLR. A total of 46 participants, 8-16 weeks post-surgery, will be recruited and randomly allocated into either the BFR group or the IASTM group using a computer-generated randomization method with allocation concealment. Participants in both groups will receive interventions twice weekly for 8 weeks, in addition to standard postoperative physiotherapy. The BFR group will perform low-load quadriceps strengthening exercises under individualized occlusion pressure, while the IASTM group will receive structured soft tissue mobilization using specialized tools along with conventional rehabilitation exercises. Outcome measures will include quadriceps muscle strength assessed using a handheld dynamometer, pain intensity measured with the Numeric Pain Rating Scale (NPRS), knee ROM assessed using a goniometer, and kinesiophobia evaluated using the Tampa Scale of Kinesiophobia (TSK-17). Assessments will be conducted at baseline and after completion of the intervention period by blinded outcome assessors. The findings of this study will provide comparative evidence regarding the effectiveness of BFR and IASTM in improving both physical and psychological outcomes during early rehabilitation after ACLR. This may assist clinicians in selecting the most appropriate adjunctive treatment to optimize recovery and enhance return-to-function in this patient population.

Interventions

OTHERBlood Flow Restriction Training

Participants will receive Blood Flow Restriction Training as an adjunct to standard postoperative physiotherapy following ACL reconstruction. A pneumatic cuff will be applied to the proximal thigh at individualized occlusion pressure to allow low-load exercise under restricted blood flow conditions. The exercise program will include straight leg raises, quadriceps sets, and seated/short-arc knee extensions. Training will focus on low-load quadriceps strengthening to promote muscle activation and recovery. The intervention will be performed twice weekly for 8 weeks under physiotherapist supervision. Safety, pain response, and limb tolerance will be continuously monitored during all sessions.

Participants will receive Instrument-Assisted Soft Tissue Mobilization as an adjunct to standard postoperative physiotherapy following ACL reconstruction. Specialized stainless-steel instruments will be used to apply controlled mechanical pressure to soft tissues around the knee region. Treatment will target peri-patellar structures, quadriceps, hamstrings, and surrounding thigh musculature. The intervention aims to improve tissue mobility, reduce pain, and enhance range of motion. Sessions will be conducted twice weekly for 8 weeks under trained physiotherapist supervision. Each session will be standardized with continuous monitoring of pain response and treatment tolerance.

Sponsors

Lahore University of Biological and Applied Sciences
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18 and 40 years. * Both genders. * Undergoing Primary Unilateral ACLR (using autologous tendon graft). * Medically cleared for low load rehabilitation (Wound healed, stable graft per surgeon). * Active knee flexion of ≥100° on the operative limb. * 8-16 weeks after reconstructive surgery. * Willing to comply with all rehabilitation sessions and follow up assessments; give informed consent

Exclusion criteria

* Significant meniscectomy requiring protected weight-bearing * Active DVT, vascular disease, uncontrolled hypertension or other BFR contraindications * Patients exhibiting extension lag (inability to achieve full active knee extension) on the operated limb. * Neuromuscular disorders * Skin lesions preventing IASTM * Pregnancy * Contraindications to exercise

Design outcomes

Primary

MeasureTime frameDescription
Quadriceps Muscle StrengthBaseline and 8 weeks post-interventionQuadriceps strength will be assessed using a handheld dynamometer to measure maximal isometric knee extensor force in a standardized seated position. The highest value from repeated trials will be recorded for analysis.
Pain IntensityBaseline and 8 weeks post-interventionPain will be assessed using the Numeric Pain Rating Scale (NPRS), where participants rate their knee pain on an 11-point scale from 0 (no pain) to 10 (worst possible pain).

Countries

Pakistan

Contacts

CONTACTDr Shoaib Waqas, Phd
shoaib.waqas@ubas.edu.pk+92 302 4552109
STUDY_DIRECTORDr Shaoib Waqas, Phd

Lahore University of Biological and Applied Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026