Post-mastectomy Pain SyndromeNCT06658314
Comparison of Kinesiotaping and Graded Exposure Therapy on Kinesiophobia in Post-Mastectomy Patients
A study testing Experimental interventional group 1(Kinesiotaping) and Experimental interventional group II (Graded exposure therapy) in people with Post-mastectomy Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to compare the effect of Comparison of Kinesiotaping and Graded exposure therapy on Kinesiophobia in Post-Mastectomy patients. The sample size was 30. The subjects were divided in two groups, 15 subjects in kinesiotaping group and 15 in graded exposure therapy group. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- Experimental interventional group 1(Kinesiotaping) and Experimental interventional group II (Graded exposure therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 19 Jun 2025
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females
- Age between 30-60 years.
- Post-Mastectomy patients (not more than 4 weeks).
- Tempa -11 score >23.
Who cannot join
- Any shoulder dislocations/fracture.
- Any known neurological impairments i.e. radiculopathy
- Bilateral mastectomy
- Known Cardiac issues
- Patients undergoing chemotherapy
- Any known allergies to kinesiotaping
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to compare the effect of Comparison of Kinesiotaping and Graded exposure therapy on Kinesiophobia in Post-Mastectomy patients. The sample size was 30. The subjects were divided in two groups, 15 subjects in kinesiotaping group and 15 in graded exposure therapy group. Study duration was of 1 year. Sampling technique applied was nonprobability Convenience sampling technique. Patients had recently undergone mastectomy procedure age between 30 to 60 years and mean Tempa- 11 score of >23 were included. Tools used in the study are Tempa -11 for kinesiophobia, NPRS for Pain, SPADI for Functional outcome measure. Data was be analyzed through SPSS 26.
Read the detailed description
Mastectomy is a procedure performed as a part of treatment for breast cancer, which entails removal of entire breast tissue. Breast cancer is a condition where abnormal cells in the breasts proliferate and eventually develop tumor. It is the most prevalent form of cancer accounting for 23% of all the newly diagnosed cancers. There are several types of mastectomy procedures including complete mastectomy, radical mastectomy and modified radical mastectomy. After mastectomy, many possible complications and side effects can occur including seroma, lymphedema, pain, restricted range of motion, kinesiophobia, infection etc. and all these complications required special care and treatment to improve patient's quality of life. Breast cancer survivor often develop fear of movement called kinesiophobia either due to pain or other psychological factors. It is the excessive, irrational, and debilitating fear of movement or physical activity. This fear of movement is linked to a feeling of susceptibility to injury from movement. As a result of using the painful area less due to the fear of increased pain from movement, acute pain can develop into persistent and chronic pain that in return increase hospital stay and decrease quality of life which increase the financial burden on individual. According to the recent studies kinesiophobia is one of the parameters found in post-mastectomy patients with mean Tempa -11 score of 24 in Pakistani populations.
Post mastectomy complications are mostly manageable, and studies show significant improvement in patient's symptoms. Shoulder disability, pain and ROM are addressed in many studies but managing kinesiophobia in early stages after mastectomy still needs to be further discussed
- Conditions
- Post-mastectomy Pain Syndrome
- Being tested
- Experimental interventional group 1(Kinesiotaping), Experimental interventional group II (Graded exposure therapy)
- Keywords
- Kinesiophobia, Kinesiotaping, Graded exposure therapy, Post-mastectomy patients
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental interventional group 1(Kinesiotaping)Other
Kinesiotape will be applied by using two I-bands application technique:
Short band: to apply this ask the patient to move your arm behind her back as much as possible, then apply kinesiotape at the anterior glenohumeral joint.
Longer band: to apply this ask the patient to horizontal adduct her arm as much as possible, than apply kinesiotape targeting the posterior side of glenohumeral joint.
Apply both these band with paper-off stretch for 3-5 days or as depending upon skin sensitivity and tape adherence.
Kinesiotape will be applied once a week for total time period of 3 weeks.
Experimental interventional group II (Graded exposure therapy)Other
First week: gentle arm raises with 10 repetitions/day, slow and controlled stretch 25 to 50% force with 5 repetitions, passive internal and external rotations (with towel) with 5 repetitions each/day.
Second week: overhead arm raises (wall climbing) with 10 repetitions/day, pendulum exercises 10 repetitions/day, cross arm stretches 5 repetitions/day, active internal and external rotations with 5 repetitions each/day.
Third week: resistance exercises (initially with minimum weight or manual resistance), scapular squeezes 10 repetitions/day, gentle chest stretches 5 repetitions/day and gentle stretch with 75 to 100 % force 5 repetitions each/day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: interventional group 1(Kinesiotaping) | Active comparator | Kinesiotape will be applied by using two I-bands application technique. It will be applied once a week for 3 to 5 days and total time period of 3 weeks. Receives: Other: Experimental interventional group 1(Kinesiotaping) |
| Experimental :interventional group II (Graded exposure therapy) | Experimental | Graded exposure therapy consists of set of exercises, performed for 3 weeks with 3 sessions per week. Each exercise protocol has 5 to 10 repetitions per day. Receives: Other: Experimental interventional group II (Graded exposure therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tempa-11 Scale
Tempa-11 Scale is used to measure Kinesiophobia. This questionnaire has 11 items with the total score of 44, 11 being the lowest possible score and 44 being the highest
Measured: Kinesiophobia will be assessed at baseline to 3rd week
Secondary outcomes (2)
Numeric Pain Rating Scale
Numeric pain rating scale is used to assess pain. Numeric pain rating scale is a 11-item scale comprising usually of horizonal or vertical line with 0 to 10 ratings between the two extremes.
Measured: Pain will be assessed at baseline to 3rd week
SPADI
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two main items, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual face during various activities of daily living that require upper-extremity use.
Measured: it will be assessed at baseline to 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Nov 2024
- Primary completion15 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658314
- Sponsor's protocol ID
- RiphahIU Madiha Bashir
- Status last verified
- Jul 2025
- First submitted
- 24 Oct 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kinesiotaping and Graded Exposure Therapy on Kinesiophobia in Post-Mastectomy Patients
- ClinicalTrials.gov ID
- NCT06658314
- Acronym / sponsor ID
- RiphahIU Madiha Bashir
- Conditions
- Post-mastectomy Pain Syndrome
- Keywords
- Kinesiophobia, Kinesiotaping, Graded exposure therapy, Post-mastectomy patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 26 Oct 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.
The aim of this research is to compare the effect of Comparison of Kinesiotaping and Graded exposure therapy on Kinesiophobia in Post-Mastectomy patients. The sample size was 30. The subjects were divided in two groups, 15 subjects in kinesiotaping group and 15 in graded exposure therapy group. Study duration was of 1 year. Sampling technique applied was nonprobability Convenience sampling technique. Patients had recently undergone mastectomy procedure age between 30 to 60 years and mean Tempa- 11 score of >23 were included. Tools used in the study are Tempa -11 for kinesiophobia, NPRS for Pain, SPADI for Functional outcome measure. Data was be analyzed through SPSS 26.
Detailed description
Mastectomy is a procedure performed as a part of treatment for breast cancer, which entails removal of entire breast tissue. Breast cancer is a condition where abnormal cells in the breasts proliferate and eventually develop tumor. It is the most prevalent form of cancer accounting for 23% of all the newly diagnosed cancers. There are several types of mastectomy procedures including complete mastectomy, radical mastectomy and modified radical mastectomy. After mastectomy, many possible complications and side effects can occur including seroma, lymphedema, pain, restricted range of motion, kinesiophobia, infection etc. and all these complications required special care and treatment to improve patient's quality of life. Breast cancer survivor often develop fear of movement called kinesiophobia either due to pain or other psychological factors. It is the excessive, irrational, and debilitating fear of movement or physical activity. This fear of movement is linked to a feeling of susceptibility to injury from movement. As a result of using the painful area less due to the fear of increased pain from movement, acute pain can develop into persistent and chronic pain that in return increase hospital stay and decrease quality of life which increase the financial burden on individual. According to the recent studies kinesiophobia is one of the parameters found in post-mastectomy patients with mean Tempa -11 score of 24 in Pakistani populations.
Post mastectomy complications are mostly manageable, and studies show significant improvement in patient's symptoms. Shoulder disability, pain and ROM are addressed in many studies but managing kinesiophobia in early stages after mastectomy still needs to be further discussed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: interventional group 1(Kinesiotaping) | Active comparator | Other: Experimental interventional group 1(Kinesiotaping)Kinesiotape will be applied by using two I-bands application technique. It will be applied once a week for 3 to 5 days and total time period of 3 weeks. |
| Experimental :interventional group II (Graded exposure therapy) | Experimental | Other: Experimental interventional group II (Graded exposure therapy)Graded exposure therapy consists of set of exercises, performed for 3 weeks with 3 sessions per week. Each exercise protocol has 5 to 10 repetitions per day. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females
- Age between 30-60 years.
- Post-Mastectomy patients (not more than 4 weeks).
- Tempa -11 score >23.
Key exclusion criteria (6 listed)
- Any shoulder dislocations/fracture.
- Any known neurological impairments i.e. radiculopathy
- Bilateral mastectomy
- Known Cardiac issues
- Patients undergoing chemotherapy
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 |
|---|---|---|
| Experimental interventional group 1(Kinesiotaping)Kinesiotape will be applied by using two I-bands application technique: Short band: to apply this ask the patient to move your arm behind her back as much as possible, then apply kinesiotape at the anterior glenohumeral joint. Longer band: to apply this ask the patient to horizontal adduct her arm as much as possible, than apply kinesiotape targeting the posterior side of glenohumeral joint. Apply both these band with paper-off stretch for 3-5 days or as depending upon skin sensitivity and tape adherence. Kinesiotape will be applied once a week for total time period of 3 weeks. | Other | Experimental: interventional group 1(Kinesiotaping) |
| Experimental interventional group II (Graded exposure therapy)First week: gentle arm raises with 10 repetitions/day, slow and controlled stretch 25 to 50% force with 5 repetitions, passive internal and external rotations (with towel) with 5 repetitions each/day. Second week: overhead arm raises (wall climbing) with 10 repetitions/day, pendulum exercises 10 repetitions/day, cross arm stretches 5 repetitions/day, active internal and external rotations with 5 repetitions each/day. Third week: resistance exercises (initially with minimum weight or manual resistance), scapular squeezes 10 repetitions/day, gentle chest stretches 5 repetitions/day and gentle stretch with 75 to 100 % force 5 repetitions each/day. | Other | Experimental :interventional group II (Graded exposure therapy) |
Primary outcome
Tempa-11 Scale
Time frame: Kinesiophobia will be assessed at baseline to 3rd week
Tempa-11 Scale is used to measure Kinesiophobia. This questionnaire has 11 items with the total score of 44, 11 being the lowest possible score and 44 being the highest
2 secondary outcomes
Numeric Pain Rating Scale
Time frame: Pain will be assessed at baseline to 3rd week
SPADI
Time frame: it will be assessed at baseline to 3rd 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 3 Jul 2025.
- 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.
Aisha Razzaq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental interventional group 1(Kinesiotaping) and Experimental interventional group II (Graded exposure therapy) in people with Post-mastectomy Pain Syndrome, run by Riphah International University 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 6 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 3 Jul 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?
Tempa-11 Scale (time frame: Kinesiophobia will be assessed at baseline to 3rd week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.