PainNCT06551922
Effects of IASTM With and Without CT on Pain, ROM, and Functional Disability in Post-Operative Knee Stiffness Patients
A study testing Instrumental Soft Tissue Mobilization Technique with Conservative Treatment and Conservative Treatment in people with Pain and Pain, Postoperative, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Pain, Pain, Postoperative, Pain, Joint
- What is being tested?
- Instrumental Soft Tissue Mobilization Technique with Conservative Treatment and Conservative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jan 2024to 21 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pain, Pain, Postoperative, Pain, Joint, Knee Pain Chronic
- Being tested
- Instrumental Soft Tissue Mobilization Technique with Conservative Treatment, Conservative Treatment
- Keywords
- Range of motion, Knee Stiffness, Functional Disability, Conservative treatment, Instrument-Assisted Soft Tissue Mobilization
- Medical subject headings
- Pain, Pain, Postoperative, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumental Soft Tissue Mobilization Technique with 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.
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 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks (baseline, third week and then at the end of the sixth week)
Range of motion
Range of motion measured using a goniometer
Measured: 6 weeks (baseline, third week and then at the end of the sixth week)
Secondary outcomes (1)
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
Measured: 6 weeks (baseline, third week and then at the end of the sixth week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start28 Jan 2024
- Primary completion14 Oct 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group A (Instrumental Soft Tissue Mobilization Technique with Conservative Treatment) * Group B (Conservative Treatment Only)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawera Ali, University of Lahore
- Investigators
- Asim Arif, M.Phil MSK, Principal investigator, University of LahoreAlishba Mustansar, M.Phil./tDPT, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551922
- Sponsor's protocol ID
- REC-UOL-/198/08/24
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35317254Meena 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.
PubMed 35689683Cutie MR, Lordi NG. Compatibility of verapamil hydrochloride injection in commonly used large-volume parenterals. Am J Hosp Pharm. 1980 May;37(5):675-6.
PubMed 7386476
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06551922
- Acronym / sponsor ID
- REC-UOL-/198/08/24
- Conditions
- Pain, Pain, Postoperative, Pain, Joint, Knee Pain Chronic
- Keywords
- Range of motion, Knee Stiffness, Functional Disability, Conservative treatment, Instrument-Assisted Soft Tissue Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * Group A (Instrumental Soft Tissue Mobilization Technique with Conservative Treatment) * Group B (Conservative Treatment Only)
| Arm | Type | Receives |
|---|---|---|
| Instrumental Soft Tissue Mobilization Technique with Conservative Treatment | Experimental | Combination Product: Instrumental Soft Tissue Mobilization Technique with Conservative TreatmentApply 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. |
| Conservative Treatment | Experimental | Combination Product: Conservative TreatmentFor 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumental Soft Tissue Mobilization Technique with Conservative TreatmentTENS: 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). | Combination product | Instrumental Soft Tissue Mobilization Technique with Conservative Treatment |
| Conservative TreatmentTENS: 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). | Combination product | Conservative Treatment |
Primary outcome
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.
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
1 secondary outcome
Functional disability
Time frame: 6 weeks (baseline, third week and then at the end of the sixth week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- BackgroundMubashar, 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.
- BackgroundPoliakov, 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.
- BackgroundPurbia, C. (2023). Effectiveness of KIASTM technique applied only quadriceps muscle for knee pain. International Journal of Orthopaedics, 9(3), 379-383.
- Results publication: PubMed 35317254Lim 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.
- Results publication: PubMed 35689683Meena 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.
- Results publication: PubMed 7386476Cutie MR, Lordi NG. Compatibility of verapamil hydrochloride injection in commonly used large-volume parenterals. Am J Hosp Pharm. 1980 May;37(5):675-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asim Arif, M.Phil MSK principal investigator
University of Lahore
Alishba Mustansar, M.Phil./tDPT study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumental Soft Tissue Mobilization Technique with Conservative Treatment and Conservative Treatment in people with Pain and Pain, Postoperative, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 weeks (baseline, third week and then at the end of the sixth week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551922, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.