Effects of IASTM With and Without CT on Pain, ROM, and Functional Disability in Post-Operative Knee Stiffness Patients

NCT ID: NCT06551922

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-28
• Study Completion Date: 2024-12-21

Brief Summary

This single-blinded randomized control study aimed to determine the effects of instrumental soft tissue mobilization technique with and without conservative treatment in post-operative knee stiffness patients. This study recruited 84 participants who fulfilled the inclusion criteria and were randomly divided into experimental and control groups using the lottery method. The assessor was unaware of the treatment given to both groups. Data were collected at baseline, at the end of the third week, and at the end of the sixth week. Baseline assessments were conducted before the intervention. Post-intervention assessments were conducted immediately after the intervention. This study aimed to investigate the effectiveness of IASTM, both with and without traditional conservative treatment methods, in improving pain, range of motion, and functional ability in patients experiencing post-operative knee stiffness. By examining these factors, we gained valuable insights into the potential of IASTM as a therapeutic intervention for this challenging condition.

Detailed Description

Instrument-Assisted Soft Tissue Mobilization (IASTM) is emerging as a valuable tool for physiotherapists, offering a range of benefits for both practitioners and patients. By integrating IASTM with traditional methods, physiotherapists can elevate the standard of care, improve patient outcomes, and even contribute to a healthier community.

Study Design:

• Randomized Control Trial

Screening:

• Patients were screened to meet inclusion criteria. The consent form was taken from patients and then randomly allocated into two groups ( 42 in each group).

Randomization:

• Patients fulfilling the inclusion criteria were randomly divided into experimental and control groups using the lottery method.

Blinding:

• The study was single-blinded. The assessor was unaware of the treatment given to both groups.

Assessment:

• Data was collected at baseline, at the end of the third week and the end of 6th week. Baseline assessments were conducted before the intervention. Post-intervention assessments were conducted immediately after the intervention.

Intervention:

• Group A (Instrumental Soft Tissue Mobilization Technique with Conservative Treatment)
• Group B (Conservative Treatment Only)

Progress Monitoring:

• Treatment intensity and exercise difficulty were progressively adjusted for both groups throughout the intervention based on participant tolerance and progress.

Ethical Considerations:

• This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.

Data Analysis:

• Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Conditions

Pain; Pain, Postoperative; Pain, Joint; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Instrumental Soft Tissue Mobilization Technique with Conservative Treatment

Apply TENS for 10 minutes to administer a microcurrent therapy to participants. The IASTM was applied for 90 seconds- 2 minutes on each muscle along with the stretching exercises. The intervention was applied 3 times per week.

Muscle involved:

• Hip Adductors
• Hamstrings
• Quadriceps
• Patellar tendon
• Iliotibial band
• Calf muscles.

Group Type: EXPERIMENTAL

Instrumental Soft Tissue Mobilization Technique with Conservative Treatment

Intervention Type: COMBINATION_PRODUCT

TENS: Apply TENS for 10 minutes on the greater trochanter and the area just above the lateral knee joint line, adhesive electrodes were positioned.

Frequency: 3 times per week. Duration: 90 seconds- 2 minutes on each muscle (Purbia, 2023). Technique: A therapist uses Ergon tools to apply gentle pressure and strokes along the targeted muscles and fascial tissues. Different IASTM techniques, like stroking, raking, and hooking, address specific tissue restrictions. The therapist should continue the IASTM technique for 5-10 minutes, or until the stiffness in the knee is reduced (Mubashar et al., 2022; Purbia, 2023).

Conservative Treatment: Stretching exercises for the hamstrings and quadriceps to improve flexibility and reduce tension. Affected iliotibialband. Hold for 30 seconds. Uncross your legs and stand up straight again. Repeat four more times (Mubashar et al., 2022).

Conservative Treatment

For conservative treatment apply TENS for 10 minutes to administer a micro current therapy to participants. Than Stretching exercises ( Hamstrings and Quadriceps), Strengthening exercises (Quadriceps, Hamstring, Calf ), Balance exercises and Ice Therapy.

Group Type: EXPERIMENTAL

Conservative Treatment

Intervention Type: COMBINATION_PRODUCT

TENS: Apply TENS for 10 minutes on the greater trochanter and the area just above the lateral knee joint line, adhesive electrodes were positioned.

Stretching exercises with hold for 30 seconds. Uncross your legs and stand up straight again (Mubashar et al., 2022).

Quadriceps Strengthening: Perform exercises like straight leg raises, seated leg press and squats to strengthen (Lim & Al-Dadah, 2022).

Hamstring Strengthening: Include exercises like leg curls to strengthen the hamstring muscles (Lim & Al-Dadah, 2022).

Calf Strengthening: Perform calf raises to strengthen the calf muscles (Lim & Al-Dadah, 2022).

Balance Exercises: Incorporate balance exercises like single-leg stands on a foam pad (Lim & Al-Dadah, 2022).

Ice Therapy: Apply ice packs to the affected knee for 15-20 minutes (Lim & Al-Dadah, 2022).

Interventions

Instrumental Soft Tissue Mobilization Technique with Conservative Treatment

TENS: Apply TENS for 10 minutes on the greater trochanter and the area just above the lateral knee joint line, adhesive electrodes were positioned.

Frequency: 3 times per week. Duration: 90 seconds- 2 minutes on each muscle (Purbia, 2023). Technique: A therapist uses Ergon tools to apply gentle pressure and strokes along the targeted muscles and fascial tissues. Different IASTM techniques, like stroking, raking, and hooking, address specific tissue restrictions. The therapist should continue the IASTM technique for 5-10 minutes, or until the stiffness in the knee is reduced (Mubashar et al., 2022; Purbia, 2023).

Conservative Treatment: Stretching exercises for the hamstrings and quadriceps to improve flexibility and reduce tension. Affected iliotibialband. Hold for 30 seconds. Uncross your legs and stand up straight again. Repeat four more times (Mubashar et al., 2022).

Intervention Type: COMBINATION_PRODUCT

Conservative Treatment

TENS: Apply TENS for 10 minutes on the greater trochanter and the area just above the lateral knee joint line, adhesive electrodes were positioned.

Stretching exercises with hold for 30 seconds. Uncross your legs and stand up straight again (Mubashar et al., 2022).

Quadriceps Strengthening: Perform exercises like straight leg raises, seated leg press and squats to strengthen (Lim & Al-Dadah, 2022).

Hamstring Strengthening: Include exercises like leg curls to strengthen the hamstring muscles (Lim & Al-Dadah, 2022).

Calf Strengthening: Perform calf raises to strengthen the calf muscles (Lim & Al-Dadah, 2022).

Balance Exercises: Incorporate balance exercises like single-leg stands on a foam pad (Lim & Al-Dadah, 2022).

Ice Therapy: Apply ice packs to the affected knee for 15-20 minutes (Lim & Al-Dadah, 2022).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Participants aged 25 to 50 years (Meena et al., 2023)
• Participants of both genders (Meena et al., 2023)
• Participants who have undergone post-operative knee stiffness surgery (Meena et al., 2023)
• Patients having knee fracture (Poliakov et al., 2020).

Exclusion Criteria

• Patients with total knee replacement (Poliakov et al., 2020).
• Participants with knee osteoarthritis or other knee conditions not related to post-operative knee stiffness (Meena et al., 2023)
• Participants with other joint conditions not related to the knee (Mezey et al., 2023)
• Post-operative knee stiffness patients with comorbidities that may affect the outcome of the study (Mezey et al., 2023)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Sawera Ali

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asim Arif, M.Phil MSK

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Alishba Mustansar, M.Phil./tDPT

Role: STUDY_DIRECTOR

University of Lahore

Locations

University of Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Mubashar, H., Hassan, D., & Bushra, M. (2022). Effects of Instrumented Assisted Soft Tissue Mobilization (IASTM) Technique Versus Stretching on Ililotibal Band in Patients with Anterior Knee Pain. Pakistan Journal of Medical & Health Sciences, 16(11), 353-353.

Reference Type: BACKGROUND

Poliakov, A., Pakhaliuk, V., & Popov, V. L. (2020). Current trends in improving of artificial joints design and technologies for their arthroplasty. Frontiers in Mechanical Engineering, 6, 4.

Reference Type: BACKGROUND

Purbia, C. (2023). Effectiveness of KIASTM technique applied only quadriceps muscle for knee pain. International Journal of Orthopaedics, 9(3), 379-383.

Reference Type: BACKGROUND

Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.

Reference Type: RESULT

PMID: 35317254 (View on PubMed)

Meena A, Hoser C, Abermann E, Hepperger C, Raj A, Fink C. Total knee arthroplasty improves sports activity and the patient-reported functional outcome at mid-term follow-up. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):905-913. doi: 10.1007/s00167-022-07025-z. Epub 2022 Jun 11.

Reference Type: RESULT

PMID: 35689683 (View on PubMed)

Cutie MR, Lordi NG. Compatibility of verapamil hydrochloride injection in commonly used large-volume parenterals. Am J Hosp Pharm. 1980 May;37(5):675-6.

Reference Type: RESULT

PMID: 7386476 (View on PubMed)

Other Identifiers

REC-UOL-/198/08/24

Identifier Type: -

Identifier Source: org_study_id