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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Progressive Muscle Relaxation Technique
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.
Other: Range of Motion and Stretching Exercises
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.
Other: Range of Motion and Stretching Exercises
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline (day 1) and post-intervention (day 4-5)
Change in Quality of Life
Time Frame: Baseline (day 1) and post-intervention (day 4-5)
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.
Baseline (day 1) and post-intervention (day 4-5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Faisalabad

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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