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

Not Applicable

Completed

• Conditions: Pain; Pain, Joint; Knee Pain Chronic; Pain, Postoperative

• Registration Number: NCT06551922
• Lead Sponsor: University of Lahore

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.

Study Timeline

• Study Start: 2024-01-28
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Primary Completion: 2024-10-14
• Study Completion: 2024-12-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	6 weeks (baseline, third week and then at the end of the sixth week)	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.
Range of motion	6 weeks (baseline, third week and then at the end of the sixth week)	Range of motion measured using a goniometer

Secondary Outcome Measures

Name	Time	Method
Functional disability	6 weeks (baseline, third week and then at the end of the sixth week)	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

Trial Locations

Locations (1)

University of Lahore; 🇵🇰 Lahore, Punjab, Pakistan