| CTRI Number |
CTRI/2025/07/092097 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of PENS Vs Dry Needling in patients with Trigger Points |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness of Percutaneous Electrical Nerve Stimulation (PENS) and Dry Needling on ph of trigger point, Pain Pressure Threshold and Quality of Life as against Conventional Treatment in patients with Levator Scapulae Trigger Point in Medical Professionals: A Three Arm Parallel Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAITHILI DESHPANDE |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Sawangi Wardha Ravi Nair Physiotherapy college, sawangi wardha Wardha MAHARASHTRA 440025 India |
| Phone |
09082955722 |
| Fax |
|
| Email |
deshpandemaithili5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MAITHILI DESHPANDE |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy college, sawangi wardha Ravi Nair Physiotherapy college, sawangi wardha Wardha MAHARASHTRA 440025 India |
| Phone |
09082955722 |
| Fax |
|
| Email |
deshpandemaithili5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
MAITHILI DESHPANDE |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy college, sawangi wardha Ravi Nair Physiotherapy college, sawangi wardha Wardha MAHARASHTRA 440025 India |
| Phone |
09082955722 |
| Fax |
|
| Email |
deshpandemaithili5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy college, MSK OPD, Sawangi wardha |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy college, sawangi wardha 442005 |
| 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 |
| Maithili Deshpande |
Ravi Nair Physiotherapy college MSK OPD |
MSK OPD Sawangi Wardha Wardha MAHARASHTRA |
09082955722
deshpandemaithili5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ravi Nair Physiotherapy College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatment |
After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness. |
| Intervention |
PENS, Dry Needling |
After the ethical clearance from the University, participants with chronic neck pain with myofascial trigger point in Levator scapulae muscle will be recruited from Physiotherapy OPD of Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha and OPD of Ravi Nair Physiotherapy College, Salod, Wardha. Once given consent and assent, these participants will be divided into two groups by simple random sampling by chit method.
All the patients will be initially questioned about age, gender, and duration of pain. Then all subjects will be evaluated for ph of trigger point, Pain Pressure threshold and Quality of life method will be used on session 1 pre-treatment and on session 9 post-treatment.
The treatment procedure will be conducted 3 times a week excluding weekends, for total of 9 sessions for 15-20 mins per session.
GROUP A: In the group A, Percutaneous electrical nerve stimulation will then applied to the trigger point in Levator scapulae muscle. Patient will be in prone position lying with both arm in abduction and head resting over the hands to relax the muscle that enables easy palpation of the muscle bulk. Head will be in neutral position. The needle of 40-50mm will be inserted. The needle Probe were connected to the alligator electrodes, with each lead connected to one positive and one negative probe. The leads were connected to the electrical generator with frequency of 15Hz and 30 Hz. After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness.
GROUP B: In the group A, Dry Needling will then applied to the trigger point in Levator scapulae muscle. Patient will be in prone position lying with both arm in abduction and head resting over the hands to relax the muscle that enables easy palpation of the muscle bulk. Head will be in neutral position. The needle of 40-50mm will be inserted. The patient will be aware that Levator scapulae muscle will respond strongly and strong twitch response will be felt. After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness.
day 1 pre treatment and day 21 post treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. A minimum of 1 palpable trigger point in Levator scapulae muscle.
2. Individual aging between 18-40 yrs.
3. Positive jump sign characterized by patient vocalization or withdrawal.
|
|
| ExclusionCriteria |
| Details |
1. History of fracture of neck and upper back region.
2. History of referred pain due to cervical pathology.
3. Dermatitis over upper back region.
4. Un-cooperative patient.
5. Subjects with Needle Phobia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ph of trigger point, pain pressure threshold, Quality of life |
pre on day 1 and post day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
outcome assessed on day 1 pre treatment & day 21 post treatment |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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="5" 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
|
Myofascial pain, which is brought on
by myofascial trigger points, is a typical source of musculoskeletal pain
(MTrPs). Myofascial pain symptoms are caused by MTrPs, which are described as
excruciatingly sensitive places in discrete taut bands of stiffened muscle.
MTrPs can be deactivated by manual methods, spray and stretch, and trigger
point needling. When necessary, MTrPs inactivation may be supplemented with
ergonomic guidance, active workouts, posture correction, and relaxation. Rarely
do comprehensive assessments of the effectiveness of conservative therapies in
individuals with neck pain include the treatment of MTrPs. Although
well-designed controlled studies are lacking, a few of case studies have
suggested that treating MTrPs in patients with neck discomfort may be useful.
Chronic nerve pain, including headaches and post-operative
pain, is also treated using percutaneous electrical nerve stimulation (PENS)
which is a skilled technique where electrical stimulation is applied via small needles which
penetrate the skin.
Intra muscular manual therapy or Dry
Needling (DN) is an adept intervention used by physical therapists that treats
neuromusculoskeletal pain and mobility problems by inserting a small filiform
needle into the skin and stimulating the underlying myofascial trigger points,
muscles, and connective tissues.
Trigger points have the potential to
refer pain to far-off areas of the body. To release/inactivate the trigger
points and alleviate pain, physical therapists use Dry Needling. Dry Needling,
according to preliminary study, enhances pain management, lessens muscular
tension, normalizes biochemical and electrical dysfunction of motor endplates,
and speeds up the transition back to active rehabilitation.
There is limited
evidence that compare the efficacy of the two therapy modalities, even though
all the above-mentioned procedures are successful in managing myofascial pain. As a result, this study proposes to compare the
effects of Percutaneous
Electrical Stimulation and Dry Needling in the Management of Levator scapulae Trigger
point in
Dental Students. After the
ethical clearance from the University, participants with chronic neck pain with
myofascial trigger point in Levator scapulae muscle will be recruited from
Physiotherapy OPD of Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha and
OPD of Ravi Nair Physiotherapy College, Salod, Wardha. Once given consent and
assent, these participants will be divided into two groups by simple random sampling
by chit method. All the
patients will be initially questioned about age, gender, and duration of pain.
Then all subjects will be evaluated for ph of trigger point, Pain Pressure
threshold and Quality of life method will be used on session 1 pre-treatment
and on session 9 post-treatment. The treatment
procedure will be conducted 3 times a week excluding weekends, for total of 9 sessions
for 15-20 mins per session. GROUP A: In the group A,
Percutaneous electrical nerve stimulation will then applied to the trigger
point in Levator scapulae muscle. Patient will be in prone position lying with
both arm in abduction and head resting over the hands to relax the muscle that
enables easy palpation of the muscle bulk. Head will be in neutral position.
The needle of 40-50mm will be inserted. The needle Probe were connected to the
alligator electrodes, with each lead connected to one positive and one negative
probe. The leads were connected to the electrical generator with frequency of
15Hz and 30 Hz. After the treatment session, stretching to the Levator scapulae
muscle and icing will be given to avoid muscle soreness. GROUP B: In the group A, Dry
Needling will then applied to the trigger point in Levator scapulae muscle.
Patient will be in prone position lying with both arm in abduction and head
resting over the hands to relax the muscle that enables easy palpation of the
muscle bulk. Head will be in neutral position. The needle of 40-50mm will be
inserted. The patient will be aware that Levator scapulae muscle will respond
strongly and strong twitch response will be felt. After the treatment session,
stretching to the Levator scapulae muscle and icing will be given to avoid
muscle soreness. Patient will be
advised not to take any analgesics during the treatment session. The pre and
post treatment ph of Trigger point, Pain Pressure Threshold and Quality of Life
measurements will be analyzed statistically.
|