- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07623005
Progressive Muscle Relaxation for Pain and Quality of Life in Thyroid Cancer (PMRT-ThyCa)
June 1, 2026 updated by: Dr. Marium Zafar, University of Faisalabad
Effectiveness of Progressive Muscle Relaxation Technique on Pain and Quality of Life in Thyroid Cancer Patients: A Randomized Controlled Trial
Thyroid cancer patients often experience pain and reduced quality of life during chemotherapy.
This randomized controlled trial will evaluate whether Progressive Muscle Relaxation (PMR) exercises, added to routine range-of-motion exercises, reduce pain and improve quality of life compared to range-of-motion exercises alone.
Thirty-two thyroid cancer patients randomly assigned to either the PMR group or the control group.
Pain measured by using the Numeric Pain Rating Scale (NPRS) and quality of life using the FACT-G questionnaire before and after a 4-5 day intervention.
The study compared changes between groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, parallel-group, randomized controlled trial to be conducted at PINUM Cancer Hospital, Faisalabad, Pakistan.
A total of 32 patients with histologically confirmed thyroid cancer (Stage I-III) undergoing chemotherapy (1-3 sessions) will be enrolled.
Inclusion criteria: age 30-50 years, moderate pain (NPRS 3-7), baseline FACT-G score ≥80%, history of lobectomy or thyroidectomy.
Exclusion criteria: comorbidities (cardiomyopathy, respiratory disorders, severe mental illness), recent fractures or surgeries, inability to follow instructions, current practice of relaxation therapies.
Participants will be randomly allocated 1:1 using an online random number generator into two groups.
Experimental group (n=16): Progressive Muscle Relaxation Technique (PMRT) once daily for 4-5 consecutive days, each session 20-40 minutes, targeting head/neck, shoulders, arms/hands, lower back/hips, calves/thighs, and feet/toes.
Each movement involves deep inhalation, tensing for 10-20 seconds, then exhalation with relaxation.
Control group (n=16): gentle range-of-motion and stretching exercises of same frequency and duration.
Outcomes: pain (NPRS, 0-10) and quality of life (FACT-G, 4 subscales) measured at baseline and post-intervention.
Normality of data assessed by using Shapiro-Wilk test.
Between-group comparisons is performed by using Mann-Whitney U test, and within-group pre-post comparisons using Wilcoxon signed-rank test.
No adverse events are anticipated.
After study completion, results will be submitted separately in the Results Module.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically confirmed thyroid cancer (Stage I-III)
- Age 30-50 years
- Moderate pain (NPRS score 3-7)
- Baseline FACT-G score ≥80%
- Undergoing chemotherapy (1-3 sessions completed)
- History of lobectomy or thyroidectomy
- Provided written informed consent
Exclusion Criteria:
- Comorbidities (cardiomyopathy, respiratory disorders, severe mental illness)
- Recent fractures or surgeries
- Unable to comprehend or follow instructions
- Currently practicing PMR or any other relaxation therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PMR + ROM
Participants received once-daily Progressive Muscle Relaxation Technique (PMRT) plus range-of-motion (ROM) exercises for 4-5 consecutive days, 20-40 minutes per session.
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Participants were guided through sequential tensing and relaxing of six muscle groups: head/neck, shoulders/upper back, arms/hands, lower back/hips, calves/thighs, and feet/toes.
For each group, they inhaled deeply and tensed muscles for 10-20 seconds, then exhaled slowly while relaxing completely.
Each session lasted 20-40 minutes, once daily for 4-5 consecutive days.
Sessions were conducted by a trained physiotherapist in a quiet hospital room.
Participants performed gentle range-of-motion (ROM) and stretching exercises for the same muscle groups (head/neck, shoulders, arms, lower back, legs, feet), without the tensing-relaxation component of PMR.
Each session lasted 20-40 minutes, once daily for 4-5 consecutive days, supervised by the same physiotherapist.
|
|
Active Comparator: ROM
Participants received only gentle range-of-motion (ROM) and stretching exercises, once daily for 4-5 consecutive days, 20-40 minutes per session.
|
Participants performed gentle range-of-motion (ROM) and stretching exercises for the same muscle groups (head/neck, shoulders, arms, lower back, legs, feet), without the tensing-relaxation component of PMR.
Each session lasted 20-40 minutes, once daily for 4-5 consecutive days, supervised by the same physiotherapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity
Time Frame: Baseline (day 1) and post-intervention (day 4-5)
|
Pain intensity measured using the Numeric Pain Rating Scale (NPRS), an 11-point scale from 0 (no pain) to 10 (worst possible pain).
Higher scores indicate worse pain.
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Baseline (day 1) and post-intervention (day 4-5)
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|
Change in Quality of Life
Time Frame: Baseline (day 1) and post-intervention (day 4-5)
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Quality of life measured using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire covering physical, social/family, emotional, and functional well-being.
Higher scores indicate better quality of life.
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Baseline (day 1) and post-intervention (day 4-5)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2026
Primary Completion (Actual)
April 1, 2026
Study Completion (Actual)
May 15, 2026
Study Registration Dates
First Submitted
May 23, 2026
First Submitted That Met QC Criteria
June 1, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Thyroid Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Thyroid Neoplasms
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Diagnostic Techniques and Procedures
- Diagnosis
- Physical Examination
- Range of Motion, Articular
Other Study ID Numbers
- TUF/EIRB/ 206 /26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
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Children's Hospital of PhiladelphiaEli Lilly and Company; United States Department of DefenseRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
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National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
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Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
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Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
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Memorial Sloan Kettering Cancer CenterActive, not recruitingThyroid Cancer, Follicular | Thyroid Cancer | Papillary Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid Cancer | Hurthle Cell Tumor | Hurthle Cell Thyroid NeoplasiaUnited States
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H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
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