| CTRI Number |
CTRI/2025/07/090499 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| 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
|
Effect of dry needling vs Ultrasound therapy along with rhomboids strengthening exercises in reducing pain and improving strength in college students-A 4 week intervention. |
|
Scientific Title of Study
|
Effectiveness Of Dry Needling Vs. Ultrasound Therapy on Pain and Strength Associated with Rhomboid Muscle Trigger Points in College-Going Students: A 4-week Single-Blinded Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibhuti Manoj Patil |
| Designation |
MPT First year Musculoskeletalsciences |
| Affiliation |
DVVPFs College of Physiotherapy, Ahilyanagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8788613527 |
| Fax |
|
| Email |
vibhutipatil18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Syed Saqib |
| Designation |
Associate Professor Musculoskeletalsciences |
| Affiliation |
DVVPFs College of Physiotherapy, Ahilyanagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
7517410984 |
| Fax |
|
| Email |
saqibpt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibhuti Manoj Patil |
| Designation |
MPT First year Musculoskeletalsciences |
| Affiliation |
DVVPFs College of Physiotherapy, Ahilyanagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8788613527 |
| Fax |
|
| Email |
vibhutipatil18@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy,Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy, Ahmadnagar |
| Address |
Department of musculoskeletal physiotherapy basement
Dr Vithalrao Vikhe Patil college of physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vibhuti Manoj Patil |
DVVPFs College of Physiotherapy, Ahmadnagar |
Department of musculoskeletal sciences Block 1 basement DVVPFs
college of physiotherapy Oppo Govt Milk Dairy MIDC 414111
Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
08788613527
vibhutipatil18@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs College of Physiotherapy, Ahmadnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry needling therapy |
1.Patient Positioning:
Position the patient on their side for treatment (this position reduces the risk of producing a pneumothorax) while the physiotherapist will firmly hold the muscle in a pincer grasp to precisely locate the trigger point for TrP-DN. Then, a monofilament needle was directed upward across the muscle mass as it was held by the fingers to avoid any possibility of penetrating the lung and causing a pneumothorax.
Ensure the patients head is turned to one side or supported in a neutral position to maintain comfort.
2.Identification of Trigger Points:
Palpate the area between the medial border of the scapula and the spine to locate taut bands or tender nodules indicative of MTrPs.
Confirm the presence of a trigger point by reproducing the patients familiar pain upon palpation.
3.Needle Selection:
Use a sterile, single-use filiform needle, typically 13 to 25 mm in length, depending on the patients body habitus and muscle thickness.
4.Needling Technique:
After skin antisepsis, insert the needle at a 45-degree angle, directing it toward the identified trigger point.
Advance the needle slowly until a local twitch response (LTR) is elicited or the patient reports a deep ache, indicating effective trigger point engagement, and keep it for 15 mins.
5. Post-Needling Care:
Apply gentle pressure to the needled area to minimize potential bruising.
Educate the patient on possible post-treatment soreness and recommend gentle stretching exercises to maintain muscle flexibility.
|
| Comparator Agent |
Rhomboids-specific Rehabilitation exercise: |
1) Pectoralis Stretch
Stand in a doorway or corner with both arms on the wall slightly above your head. Slowly lean forward until you feel a stretch in the front of your shoulders. Hold for 15 to 30 seconds. Repeat 3 times.
2) Thoracic Extension
While sitting in a chair, clasp both arms behind your head. Gently arch backward and look up toward the ceiling. Repeat 10 times. Do this several times per day.
3) Door Frame Stretch:
Stand near a door frame. Lift the arm on your injured side straight out in front of you and grasp the door frame. Lean back, letting the pull of your body weight stretch the muscles near your shoulder blade. Hold for 15 to 30 seconds. Repeat 3 times.
4) Scapular Squeeze:
While sitting or standing with your arms by your sides, squeeze your shoulder blades together and hold for 5 seconds. Do 3 sets of 10
5) Middle Trapezius Exercise:
Lie on your stomach on a firm surface and place a folded pillow underneath your chest. Place your arms out straight to your sides with your elbows straight and thumbs toward the ceiling. Slowly raise your arms toward the ceiling as you squeeze your shoulder blades together. Lower slowly. Do 3 sets of 15. Progress to holding soup cans or small weights in your hands.
6) Thoracic Stretch:
Sit on the floor with your legs out straight in front of you. Hold your mid-thighs with your hands. Curl you head and neck toward your belly but-ton. Hold for a count of. Repeat 3 times.
7) Thoracic Side Stretch:
To stretch your right upper back, point your right elbow and shoulders forward while twisting your trunk to the left. Hold for a count of 15. Repeat 3 times. To stretch your left upper back, point your left elbow and shoulder forward while twisting your trunk to the right. Hold for a count of 10. Repeat 3 times.
8) Rowing Exercise:
Tie a piece of elastic tubing around an immovable object and grasp the ends in each hand. Keep your forearms vertical and your elbows at shoulder level and bent to 90 degrees.
|
| Intervention |
Ultrasound Therapy |
1.Patient Positioning:
Position the patient in a prone or seated posture, ensuring the upper back and scapular region are accessible and the patient is comfortable.
2.Identification of Trigger Points:
Palpate the rhomboid muscles to locate taut bands or tender nodules indicative of myofascial trigger points.
3.Ultrasound Settings:
Frequency: 1 MHz for deeper tissues, such as the rhomboid muscles.
Intensity: 1.5 to 2.0 W/cm², adjusted based on patient tolerance.
Duty Cycle: Continuous mode for thermal effects.
Duration: 5 to 10 minutes per trigger point area.
Rationale: Continuous ultrasound at 1 MHz frequency and 1.5 W/cm² intensity has been shown to effectively reduce pain and sensitivity in myofascial trigger points.
4.Application Technique:
Apply a coupling medium (ultrasound gel) to the targeted area to facilitate the effective transmission of ultrasound waves.
Move the ultrasound transducer slowly and steadily over the identified trigger point in circular or linear motions, maintaining consistent contact.
5.Treatment Frequency:
Administer ultrasound therapy 2 to 3 times per week.
Continue treatments for 4 weeks or until significant improvement is observed.
Rationale: A treatment course of 10 sessions over 2 weeks demonstrated significant pain reduction and improved function in patients with myofascial pain syndrome.
6.Monitoring and Assessment:
Evaluate pain levels using a Visual Analog Scale (VAS) before and after each session.
Assess functional improvements and muscle strength periodically throughout the treatment course.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of Rhomboid Muscle Trigger Points: Confirmed by palpation.
2.Participants experiencing chronic or recurrent upper back pain associated with trigger points for at least 4 weeks.
3. Participants should not have received dry needling, physiotherapy, or other musculoskeletal treatments targeting the muscles in the past 4 weeks.
|
|
| ExclusionCriteria |
| Details |
1.Recent Injury or Surgery: History of trauma, fractures, or surgery in the upper back, neck, or shoulder region within the past 6 months.
2.Skin infections or open wounds at the treatment site.
3. Bleeding disorders (e.g., haemophilia) or anticoagulant therapy.
4.Fear of needles (trypanophobia).
5.Regular Use of Pain Medication: Participants taking opioids, muscle relaxants, or corticosteroids that could influence pain perception. Engagement in Conflicting Treatments.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain, pain pressure threshold and strength |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
20/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study aims to find out the effectiveness of dry needling vs ultrasound therapy on pain and strength associated with the rhomboid muscle trigger points in college-going students. RCT. 38 subjects, 19 in each group, will be recruited based on inclusion and exclusion criteria. There will be 2 groups dry needling group and ultrasound therapy group, Conventional treatment will be given to all groups. Outcome measures are pain, ,pain pressure threshold and strength. Pre-intervention outcome measures will be taken. Intervention will be given for 4 weeks, and post-treatment outcome measures will be taken. follow-up will be taken after 4 weeks. The analysis and result will be
calculated. |