Improvement in quality of life of patients with myofascial pain treated with either conservative therapy only or conservative therapy with early self-physiotherapy
| ISRCTN | ISRCTN12874881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12874881 |
- Submission date
- 28/02/2025
- Registration date
- 19/03/2025
- Last edited
- 19/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Myofascial pain is a common condition that affects the muscles around the jaw, leading to discomfort and difficulty in jaw movement. Temporomandibular disorders (TMD) can significantly impact a person's quality of life by causing pain and restricting normal jaw function. This study aims to compare two treatment methods: conservative therapy alone and conservative therapy with early self-physiotherapy. The objective is to evaluate effective way of improving the quality of life for patients with myofascial pain.
Who can participate?
Participants were men and women between the ages of 20 and 40 who had been diagnosed with myofascial pain of TMJ. Those with other medical conditions, previous jaw surgeries, or severe psychological disorders were excluded in the study.
What does the study involve?
The study involved 60 patients that were randomly divided into groups:
Group A: Patients received only conservative therapy, including soft diet instructions, avoiding teeth grinding, and heat therapy.
Group B: Patients received conservative therapy along with early self-physiotherapy, which included exercises to strengthen and stretch the jaw muscles.
The quality of life of each patient was assessed before treatment and after four weeks.
What are the possible benefits and risks of participating?
Participants benefited by getting structured treatment aimed at reducing jaw pain and improving their overall quality of life. Self-physiotherapy, in particular, may help strengthen muscles and prevent future problems.
The risks were minimal, but some patients may have experienced temporary discomfort while performing the exercises.
Where is the study run from?
The study was conducted at Fatima Memorial Hospital, College of Medicine & Dentistry, Lahore, in the Department of Oral and Maxillofacial Surgery.
When is the study starting and how long is it expected to run for?
January 2019 to August 2022
Who is funding the study?
The study did not have any external funding. It was carried out as part of academic research at Fatima Memorial Hospital.
Who is the main contact?
Dr Iqra Saleem, doctoriqrasaleem@gmail.com
Contact information
Public, Scientific, Principal Investigator
Indus 46, Green Forts II Thokar Niaz Baig
lahore
-
Pakistan
 ORCID ID |
0009-0009-9755-5152 |
|---|---|
| Phone | +92 3218825239 |
| doctoriqrasaleem@gmail.com |
Study information
| Study design | Single centre interventional single blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, Hospital |
| Study type | Quality of life, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized controlled trial investigating the impact of conservative therapy alone versus conservative therapy with early self-physiotherapy on quality of life in patients with myofascial pain |
| Study objectives | Early self-physiotherapy is better than conservative therapy |
| Ethics approval(s) |
Approved 10/11/2020, Istitutional Review Board FMH College of Medicine and Dentistry (Shadman, Lahore, 54000, Pakistan; +92 3218825239; Ali.mumtaz@fmhcmd.edu.pk), ref: FMH-06-2019-IRB-636-M |
| Health condition(s) or problem(s) studied | Improving quality of life of patients of temporomandibular joint disorder |
| Intervention | Sixty-two patients diagnosed with myofascial pain were randomly allocated to either of two treatment groups using Lottery method: Group A received conservative therapy alone, while Group B underwent conservative therapy combined with early self-physiotherapy. QOL assessment was conducted at baseline and after four weeks using a validated QOL index. Statistical analysis included paired sample t-tests for within-group comparisons and independent sample t-tests for between-group comparisons. |
| Intervention type | Behavioural |
| Primary outcome measure | Validated QOL index was used to assess quality of life before and after 4 weeks of therapy |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2019 |
| Completion date | 29/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 62 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patients with myofascial pain (DC-TMD Axis 1 Group 1 only) 2. Both genders (male and female) 3. Age 20 - 40 years 4. Dentate |
| Key exclusion criteria | 1. Patients with systemic health disorders including CVS, CNS, respiratory, endocrine, systemic musculoskeletal etc. 2. Known Psychiatric or psychological conditions 3. Those not willing to participate in research 4. Those already under treatment 5. Missing data for any variable 6. Deep bite 7. Neuropathic pain 8. A history of TMJ surgery 9. Condylar fractures |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 01/08/2022 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Lahore
54000
Pakistan
Sponsor information
Hospital/treatment centre
Shadman
Lahore
54000
Pakistan
| Phone | +92-42-111-555-600 |
|---|---|
| info@fmsystem.org | |
| Website | https://www.fmsystem.org |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 07/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request doctoriqrasaleem@gmail.com |
Editorial Notes
19/03/2025: Internal review.
04/03/2025: Study's existence confirmed by the College of Physicians and Surgeons Pakistan, Research Evaluation Unit.
