Treatment of knee pain with combined instrument-assisted soft tissue mobilization
| ISRCTN | ISRCTN88098928 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88098928 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Wuhan Sports University |
| Funder | Wuhan Sports University |
- Submission date
- 28/01/2023
- Registration date
- 07/02/2023
- Last edited
- 02/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study looks at the effects of instrument-assisted soft tissue mobilization (IASTM) therapy on patellofemoral pain syndrome, a common knee condition which causes pain at the front of the knee around the area known as the patellofemoral joint. The study aims to find out if the therapy reduces patellofemoral discomfort, and improves function, strength, and joint mobility.
Who can participate?
Adult patients aged between 18 and 35 years old with patellofemoral discomfort
What does the study involve?
This study lasted for four weeks and was conducted at the Experimental Centre for Sports Rehabilitation of the Wuhan Sports University. To help the trial run smoothly, the study also included resistance training or the use of tui na, a traditional Chinese massage technique.
What are the possible benefits and risks of participating?
The ability to help people with patellofemoral discomfort, reduce or eliminate knee pain, boost lower limb strength, and regain lower limb function is the potential benefit of the project. While there is a danger that the procedure will cause soft tissue damage, this risk is low and the experiment is entirely under control.
Where is the study run from?
Wuhan Sports University (China)
When is the study starting and how long is it expected to run for?
May 2022 to October 2022
Who is funding the study?
Wuhan Sports University (China)
Who is the main contact?
Prof Lianqing Wu, 784389072@qq.com
Contact information
Public
Wuhan Institute of Physical Education
Wuhan
430079
China
 ORCID ID |
0000-0002-0221-1907 |
|---|---|
| Phone | +8618935836605 |
| 784389072@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Treatment of patellofemoral joint pain with combined instrument-assisted soft tissue mobilization |
| Study objectives | Instrument-assisted soft tissue mobilization treatment can improve the symptoms of patients with patellofemoral joint pain, including pain, function and lower limb strength. |
| Ethics approval(s) |
1. Approved 02/06/2022, Medical Ethics Committee of Wuhan Institute of Sports (No. 461 Luoyu Road, Hongshan District, Wuhan, 430079, China; +86 18935896605; liuyang121795@qq.com), ref: 2022062 2. Submitted 01/09/2022, Medical Human Ethics Review Committee of Wuhan Institute of Physical Education (Wuhan Sports University, Wuhan, 430000, China; +86 18935836605; liuyang121795@qq.com), ref: N202061 |
| Health condition(s) or problem(s) studied | Patellofemoral joint pain |
| Intervention | Patients with patellofemoral joint pain were randomly divided into an instrument-assisted soft tissue mobilization (IASTM) test group and a control group. The IASTM test group was treated with IASTM combined with resistance training while the control group received only IASTM. Both groups were treated for 4 weeks. At four time points, before treatment, after the first treatment, after the second treatment and after the third treatment, the visual analog pain score (VAS), the Lysholm score of the knee and the modified Thomas test (MTT) were compared and analyzed. Before and 4 weeks after treatment, the maximum isometric muscle strength test system of the lower limb extensor was undertaken. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | 1. Pain measured using the visual analogue pain score (VAS) assessed before the start of the experiment, and in the first and last weeks of the experiment 2. Knee-specific symptoms measured using the Lysholm Knee Scoring System assessed before the start of the experiment, and in the first and last weeks of the experiment 3. Flexibility of the iliopsoas, rectus femoris and tensor fascia latae (hip flexion contracture and hip extensibility) measured using the modified Thomas test (MTT) assessed before the start of the experiment, and in the first and last weeks of the experiment 4. Muscle strength test measured using the maximum isometric muscle strength test system of the lower limb extensor assessed before the start of the experiment and in the last week of the experiment |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 19/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Aged between 18 and 35 years old 2. Be able to cooperate with rehabilitation physiotherapy, training and follow-up, and will not withdraw from the study without reason |
| Key exclusion criteria | 1. Exogenous injury of knee joint, including bruise, hit, cut, scald, contusion, etc., without external or subcutaneous bleeding due to skin rupture 2. Abnormal natural bone structure 3. Inflammation, patellar dislocation or subluxation, knee ligament injury 4. History of arthroscopic surgery of knee joint within one year 5. Injury or discomfort of other body parts |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 18/09/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Hubei Province
Wuhan City
430079
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The data set generated during this study is not expected to be available because these data relate to the personal privacy of the subjects. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Ccomparative study of the efficacy of instrument-assisted soft tissue mobilization and massage techniques | 13/11/2023 | 01/12/2023 | Yes | No |
| Results article | Effect of combined IASTM and blood flow treatment | 31/08/2023 | 02/05/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/05/2025: Publication reference added.
01/12/2023: Publication reference added.
10/07/2023: The following changes were made to the trial record:
1. An ethics submission was added.
2. The total final enrolment was changed from 26 to 38.
3. The intention to publish date was changed from 30/01/2023 to 06/07/2023.
01/02/2023: Trial's existence confirmed by the Medical Ethics Committee of Wuhan Institute of Sports.
