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

Effects of Instrumental Soft Tissue Mobilization Technique With and Without Conservative Treatment on Pain , Range of Motion and Functional Disability in Post Operative Knee Stiffness Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Postoperative; Knee Pain Chronic; Pain, Joint
• Intervention / Treatment: Combination product: Instrumental Soft Tissue Mobilization Technique with Conservative Treatment; Combination product: Conservative Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54590
      • University of Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Experimental: 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.	Combination product: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion measured using a goniometer	6 weeks (baseline, third week and then at the end of the sixth week)
Pain Intensity	Pain level measured using a visual analog scale. It consists of a 10-centimeter line with endpoints labeled to represent the two extremes of the experience being measured. For pain, the typical endpoints are "no pain" on the left and "worst imaginable pain" on the right. For pain, a score of 0 means no pain, while a score of 10 represents the worst imaginable pain.	6 weeks (baseline, third week and then at the end of the sixth week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional disability	Functional disability measured using the Lower Extremity Functional Scale. The scale consists of 20 items that assess the patient's ability to perform various activities, such as walking, running, and climbing stairs. The objective of the LEFS is to measure patients' initial function, ongoing progress, and outcome for a wide range of lower-extremity conditions. The maximum total score is 80, indicating no functional limitations.The minimum score is 0, indicating extreme limitations. The lower the total score, the greater the disability	6 weeks (baseline, third week and then at the end of the sixth week)

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: Asim Arif, M.Phil MSK, University of Lahore; Study Director: Alishba Mustansar, M.Phil./tDPT, University of Lahore

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2024
• Primary Completion (Actual): October 14, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Conservative treatment; Range of motion; Functional Disability; Knee Stiffness; Instrument-Assisted Soft Tissue Mobilization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Joint Diseases; Pain, Postoperative; Arthralgia
• Other Study ID Numbers: REC-UOL-/198/08/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be collected from the University of Lahore Teaching Hospital, Lahore after taking informed written consent form through the questionnaires. A comparative analysis will be conducted between Group A and Group B, evaluating improvements in pain, range of motion and functional ability in patients experiencing post-operative knee stiffness. The data will be entered and analyzed using SPSS Version 24. The numerical data like age will be presented in mean ± SD. Categorical Data like gender groups will be presented in the form of frequency (Percentage). The normality of the data distribution will be test by Shipro's Wilk test and for between-group and within-group comparisons; p-value < 0.05 will be considered significant.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No