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Completed

NCT Number: NCT06551922

Effects of IASTM With and Without CT on Pain, ROM, 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.

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Key information

Conditions

Pain Arthralgia Joint Diseases Knee Pain Chronic Musculoskeletal Diseases Neurologic Manifestations Pain, Joint Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore

Lahore, Punjab Province, 54590, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Instrumental Soft Tissue Mobilization Technique with Conservative Treatment

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

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).

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Range of motion

    Time frame: 6 weeks (baseline, third week and then at the end of the sixth week)

    Range of motion measured using a goniometer

Secondary outcomes

  1. Functional disability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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