NCT06551922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

August 9, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

Range of motionKnee StiffnessFunctional DisabilityConservative treatmentInstrument-Assisted Soft Tissue Mobilization

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Range of motion

    Range of motion measured using a goniometer

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

Secondary Outcomes (1)

  • Functional disability

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

Study Arms (2)

Instrumental Soft Tissue Mobilization Technique with Conservative Treatment

EXPERIMENTAL

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

Conservative Treatment

EXPERIMENTAL

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

Interventions

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).

Instrumental Soft Tissue Mobilization Technique with Conservative Treatment
Conservative TreatmentCOMBINATION_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).

Conservative Treatment

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (6)

  • 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.

    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.

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

    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.

  • 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.

MeSH Terms

Conditions

PainPain, PostoperativeArthralgia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Asim Arif, M.Phil MSK

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Alishba Mustansar, M.Phil./tDPT

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The single-blinded assessor was utilized to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Group A (Instrumental Soft Tissue Mobilization Technique with Conservative Treatment) * Group B (Conservative Treatment Only)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

January 28, 2024

Primary Completion

October 14, 2024

Study Completion

December 21, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations