| CTRI Number |
CTRI/2025/09/095404 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of pre-radiation manual therapy on neck and shoulder dysfunction and quality of life in head and neck cancer survivors with pectoralis major myocutaneous flap and deltopectoral flap reconstruction surgeries: A randomized control trial. |
|
Scientific Title of Study
|
Impact of pre-radiation manual therapy on neck and shoulder dysfunction and quality of life in head and neck cancer survivors: A randomized control trial. |
| Trial Acronym |
NL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janhvi Jayesh Shah |
| Designation |
Pursuing masters in Oncology Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Oncology, Nehru Nagar, Belagavi.
KAHER Institute of Physiotherapy, Sagar floor, OPD no. 19, Department of Oncology, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
8850570852 |
| Fax |
|
| Email |
shahj469@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Professor and Principal, KAHER Institute of Physiotherapy Belagavi. |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Neurology, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Imtiaz Ahmed |
| Designation |
Professor and Head of Radiation Oncology |
| Affiliation |
KAHER J. N. MEDICAL COLLEGE |
| Address |
KAHER J. N. MEDICAL COLLEGE, Belagavi
KAHER J.N. MEDICAL COLLEGE, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8850570852 |
| Fax |
|
| Email |
imtidr@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy Higher Education and Research,
Nehru Nagar, Belgaum, Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy Higher Education and Research |
| Address |
Dr. Prabhakar Kore hospital, Advanced physiotherapy center, Department of Oncology department, Belagavi, Karnataka 590010 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Janhvi Jayesh Shah |
KLE Institute of Physiotherapy |
KAHER Institute of Physiotherapy, Sagar floor, Physiotherapy opd no. 19,Oncology department, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
8850570852
shahj469@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group- Usual standard care |
Frequency- 1 session per day (for 10 days before radiation and continued during the course of radiation treatment)
Intensity- 10 repetitions of each exercise per session (Exercises should be pain-free, avoiding excessive strain)
Time- 20-30 minutes per session
Type- Active Range of motion exercises, Wall ladder exercises, Wand exercises, Shoulder isometric, Neck isometric, Scapular exercises |
| Intervention |
Manual therapy- Mobilization with Movement |
Positioning: Patient in sitting or supine based on comfort and surgical considerations
Mobilization Direction: Mulligan Techniques Used for Shoulder Dysfunction
1. Posterolateral Glide (MWM for Shoulder Flexion)
2. Inferior Glide (MWM for Abduction)
3. Scapular MWM for Scapular Dyskinesis
4. Functional Sustained natural apophyseal glides/ cervical MWM
Dosage Recommendations-
Repetitions & Sets:
3 sets of 3- 6 repetitions per session (as tolerated)
1 session daily for 10 days
Sustained Mobilization:
Each mobilization should be held for 6-10 seconds while the patient actively moves through the restricted range
Progression:
Increase force and range gradually if no pain is experienced
If resistance or discomfort occurs, reduce intensity or modify direction
pmmc rehab guidelines.pdf
Patient Feedback: Mobilization should be pain-free and lead to immediate improvement in ROM or function
Duration- 30- 40 mins per session |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Head and neck cancer patients underwent PMMC or DP flap reconstruction.
Patients planned for radiation therapy post-intervention
Scheduled for radiation therapy starting post-surgery.
Healed flap with no surgical complications.
|
|
| ExclusionCriteria |
| Details |
Severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate manual therapy.
Patients with pre-existing severe shoulder and neck dysfunction.
Patients with advanced metastases
Patients with secondary suturing. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Neck dysfunction
2. Shoulder dysfunction |
1. Neck disability index scale (NDI)
2. Shoulder Pain and Disability Index (SPADI)
The following outcomes would be assessed at baseline (before 1st session, at the end of 10th session, and follow up (post radiation therapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Scapulohumeral Rhythm
2. Pain Levels
3. Functional Mobility & Strength
4. Range of Motion (ROM)
5. Quality of Life (QoL) |
1. Digital Inclinometer (Pro 360, baseline)
2. Numeric Pain Rating Scale (NPRS)
3. Manual Muscle Testing (MMT)
4. Universal Goniometer-based ROM Measurement
5. FACT Head & Neck
The following outcomes would be assessed at baseline (before 1st session, at the end of 10th session, & follow up (post radiation therapy) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgical procedures in head and neck cancer, while necessary for tumour removal and reconstruction, can cause musculoskeletal impairments, including pain, restricted range of motion (ROM), and functional disability due to muscle dissection and altered biomechanics. A regimen of exercises and patient education is an effective tool to reduce shoulder disability and improve shoulder function. The study suggests that manual therapy techniques can alleviate neck pain and improve quality of life, and recommends their use in clinical settings, but caution should be exercised when selecting these techniques for head and neck cancer survivors. MWM is associated with improved pain, mobility, and function in patients with a range of shoulder musculoskeletal disorders, and the effects are clinically meaningful. Radiation to the neck can cause a woody texture and limited mobility of the neck, enhance lymphedema, significant tightness of the neck and shoulder muscles, including the scalenes, trapezius, and sternocleidomastoid muscles. Fibrosis may cause both cosmetic and functional impairment, leading to deterioration in the quality of life. Research suggests Pain reduction, Improvement in Cervical, TMJ, and shoulder range of motion, Improved Quality of life, and reduction in disability following a combined manual therapy approach in head and neck cancer patients post radiation. Although manual therapy is often used after surgery and radiation, its benefits when applied before radiation therapy have not been well studied, particularly for HNC patients with reconstructive flap surgeries. Applying manual therapy before radiation could be an effective way to manage dysfunction early in the recovery process, potentially preventing long-term problems caused by radiation. Given the lack of research on this approach, a randomized controlled trial (RCT) is needed to determine the effectiveness of pre-radiation manual therapy in reducing neck and shoulder dysfunction in HNC patients. Such a study could provide valuable evidence to develop evidence-based rehabilitation protocols that improve patient outcomes and reduce the need for intensive post-radiation interventions. |