Clinical trial NCT06551922: Effects of IASTM With and Without CT on Pain, ROM, and Functional Disability in Post-Operative Knee Stiffness Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pain, Postoperative
Pain, Joint
Knee Pain Chronic
Keywords: Range of motion
Knee Stiffness
Functional Disability
Conservative treatment
Instrument-Assisted Soft Tissue Mobilization
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 84
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group A (Instrumental Soft Tissue Mobilization Technique with Conservative Treatment)
* Group B (Conservative Treatment Only)
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 weeks (baseline, third week and then at the end of the sixth week)
measure: Range of motion
timeFrame: 6 weeks (baseline, third week and then at the end of the sixth week)
Secondary outcomes:
measure: Functional disability
timeFrame: 6 weeks (baseline, third week and then at the end of the sixth week)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Asim Arif, M.Phil MSK
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lahore
name: Alishba Mustansar, M.Phil./tDPT
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Purbia, C. (2023). Effectiveness of KIASTM technique applied only quadriceps muscle for knee pain. International Journal of Orthopaedics, 9(3), 379-383.
citation: 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.
citation: 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.
citation: 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.