| CTRI Number |
CTRI/2024/02/062351 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dry Needling Vs Ischemic Compression Therapy For Upper Trapezius Latent Trigger Points |
|
Scientific Title of Study
|
Comparison Between Dry Needling And Ischemic Compression Therapy For Upper Trapezius Latent Trigger Points |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shriya |
| Designation |
PG SCHOLAR |
| Affiliation |
Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh |
| Address |
F1 Block,Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 201301 India |
| Phone |
8279563756 |
| Fax |
|
| Email |
shriyabhatt66@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjb Kumar Das |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh |
| Address |
Room No. 107A ,F1 Block,Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 201301 India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjb Kumar Das |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh |
| Address |
Room No. 107A ,F1 Block,Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh Sector 125, Noida, Uttar Pradesh
UTTAR PRADESH 201301 India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Univesity Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Shriya |
| Address |
F1 Block,Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh Sector 125, Noida, Uttar Pradesh 201301 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrShriya |
Amity University Uttar Pradesh Physiotherapy Clinic |
Gate no-1 Amity University Uttar Pradesh Sector 125, Noida, 201301 Gautam Buddha Nagar UTTAR PRADESH |
8279563756
shriyabhatt66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Sciences Amity University Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Needling + Passive stretching
|
The Dry needling technique for MTrPs was performed with ‘solid filiform needles’.
The exercise will require the participant to lie on their back. The skin that needs to be treated was cleaned with alcohol. Thumb and index finger were localised over the MTrp of the taut band, and the solid filiform needle was inserted into its plastic guide tube.
The tapping motion was used to insert the needle. was stopped after obtaining LTR. To cause a twitch in a muscle the needle was placed into the muscle bundle and moved in and out of the tissue, a process known as LTR (local twitch response).
If there was no twitch after two or three stellate movements, the needle was stopped. |
| Intervention |
Ischemic compression therapy + passive stretching |
Using a pincer grasp, the therapist will place the thumb and index finger over the latent trigger in this technique.
Until the tissue barrier is felt to release, pressure will be applied. Depending on the patients tolerance, the pressure will be applied intermittently at first and then continuously for 90 seconds |
| Comparator Agent |
Numeric Pain Rating Scale, Neck Disability Index, Universal Goniometer |
Goniometer is inexpensive, portable, and dependable and has been used to measure the range of motion (ROM) of joints and is considered a standard method for ROM determination. One of the procedures drawbacks is that the doctors must use both hands to perform the examinations. This makes maintaining the limbs essential stability extremely difficult and could lead to some problems when reading the angles.
• Numeric pain rating scale (NPRS)
The patient was asked to rate his or her current, least, and worst level of pain over the previous 24 hours. The patients pain level during the preceding 24 hours was represented by the mean of the three ratings . Bolton and Wilkenson have demonstrated that the NPRS is a valid and reliable tool. It is scored on an 11-point scale from 0 to 10, with 0 denoting no pain and 10 denoting the worst possible pain.
Neck disability Index (NDI)
The Neck Disability Index (NDI) is a ten-item questionnaire that measures the disability brought on by whiplash and neck pain and is based on the Oswestry Low Back Pain Index. Four things are related to subjective Symptomatology which includes level of discomfort, headache, focus, sleeping and six things that pertain to daily activities lifting, working, driving, having fun, taking care of oneself, and reading.
|
| Intervention |
Ultrasound + Passive stretching |
Patients in the US group were given continuous conventional US treatment for five minutes. The device draws intertwining circles on and around the trigger point in one-two seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Age between 18-50
• Presence of a palpable taut band in the upper trapezius muscle
• Patient with neck pain
• University going students and research scholars
• Population who signs the consent
|
|
| ExclusionCriteria |
| Details |
• Any kind of recent past or present surgical history
• Any history of headache, malignancy, vertigo
• Any neurological or cardiovascular deficits
• History of MTrPs treatment
• Any history of trauma or fall
• Any fracture conditions
• Presence of spontaneous referred pain pattern (active trigger points)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric pain rating scale (NPRS) |
Baseline and after 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability Index (NDI) |
Baseline and after 4 week |
| Cervical Range of motion |
Baseline and after 4 week |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
| NEED OF THE STUDY: - • Myofascial Triger Point (MTrPs) are frequently brought on by overuse, bad posture, or injury. The upper trapezius muscle is a common site for MTrPs and it can result in several symptoms, including stiff and painful muscles, tension headaches, neck discomfort, restricted range of motion in the neck and shoulder, referred pain to other parts of the body, dizziness, and vertigo. • Most persons with MTrPs can lessen their symptoms with the correct physiotherapeutic approach. According to research studies, different techniques were used in the treatment of trigger points. Dry needling, passive stretching and ischemia compression therapy is also significantly effective. However, the most effective management for upper trapezius latent trigger point remains an area of debate and no research was done to determine which of the three is superior. Our research will concentrate to elicit the most effective therapy among these three for latent trigger point sites. AIMS AND OBJECTIVES: – Aim: - • The aim of this study will be to evaluate and analyze the comparative effects of Dry needling and Ischemic compression therapy for upper trapezius latent trigger points. Objectives: - • To determine the efficacy of Ischemic Compression with passive stretching in improvement of cervical range, decrease in cervical pain and deduction in disability in patients of upper trapezius latent trigger points. • To determine the efficacy of Dry Needling with passive stretching | | in improvement of cervical range, decrease in cervical pain and deduction in disability in patients of upper trapezius latent trigger points. • To determine the efficacy of Ultrasound with passive stretching in improvement of cervical range, decrease in cervical pain and deduction in disability in patients of upper trapezius latent trigger points. • To compare the physiotherapeutic treatment protocol – Ischemic compression therapy with passive stretching, Dry needling with passive stretching and ultrasound in passive stretching in improvement of cervical range of motion, deduction in cervical disability and decrease cervical pain in patients for upper trapezius on latent trigger points. | | Hypothesis: - Null hypothesis (Ho) . • There is no significant effect of Ischemic compression therapy in the treatment of upper trapezius latent trigger points. • There is no significant effect of Dry needling in the treatment of upper trapezius latent trigger points. Alternate hypothesis (H1) • There is significant effect of Ischemic compression therapy in the treatment of upper trapezius latent trigger points. • There is significant effect of Dry needling in the treatment of upper trapezius latent trigger points. ’
| GROUP ALLOCATION: - Participants will be allocated into three groups, group A, group B and group C respectively. · Group A participants will receive Ischemic compression therapy + passive stretching. · Group B participants will receive Dry needling + passive stretching. · Group C participants will receive Ultrasound + passive stretching PROCEDURE: - · After receiving the ethical clearance from the ethical committee of the university, the study was further started. · Students will be selected based on inclusion criteria. · A written consent was taken from all participants, and the treatment protocol, the study type and duration of the study will be explained by the therapist. Participants, will be divided into three groups Group A, Group B or group C respectively by chit method. (Ray et al., 2020) · Either a flat palpation or pincer palpation approach method was used to identify latent trigger points. (Kumar et al.,2014) · Pre and post readings of NDI, NPRS and goniometer will be evaluated. · Pain intensity, active ROM and palpation of the latent trigger points will be evaluated through different instruments and questionnaire which includes NDI, NPRS, goniometer as an outcome measure. · The set criteria in the study included the active range of cervical lateral flexion analyzed by goniometer, pain intensity on the Numeric pain rating scale (NPRS), and NDI for cervical disability. To locate the upper trapezius LTrPs, we followed the diagnostic exploration criteria established by Simons et al. (1999); this was performed by a physiotherapist with three years of clinical experience. (Sadria et al., 2016) 1) Presence of palpable taut band in the skeletal muscle. 2) Presence of a hypersensitive tender spot in the taut band. 3) Local twitch response provoked by the snapping palpation of the taut band. 4) 4)Reproduction of the typical pain pattern of the MTrPs in response to compression. 5) Spontaneous presence of the typical referred pain pattern and/or the patient’s recognition of the referred pain as familiar. In the cases in which the first four criteria were met, the MTrP was | | | considered to be latent. • The subjects were randomized to receive either Ultrasound with passive stretching, Ischemic compression with passive stretching or Dry needling with passive stretching. • To measure cervical lateral flexion with a goniometer, follow these steps: 1. Position the patient seated in a chair with their back supported and their feet flat on the floor. 2. Place the fulcrum of the goniometer over the spinous process of C7. 3. Align the stationary arm of the goniometer with the spinous process of T1. 4. Align the moving arm of the goniometer with the dorsal midline of the head. 5. Instruct the patient to slowly tilt their head to the side being measured. 6. Read the measurement on the goniometer when the patient reaches their end range of motion Ø Passive Stretching procedure: - • A passive stretching by a therapist was applied to upper Trapezius muscle for a count of 3 repetitions with 10-seconds hold. • Participant position: - Sitting on a comfortable chair with hands on the laps. • Therapist position: - The therapist will stand behind the patient and perform a cervical flexion, rotation, and lateral flexion stretch on the opposite side. The distal clavicle and the scapula were manually stretched by depressing them with the other hand. | | For Group A :- Ischemic compression therapy + passive stretching | Using a pincer grasp, the therapist will place the thumb and index finger over the latent trigger in this technique. |  | Until the tissue barrier is felt to release, pressure will be applied. Depending on the patient’s tolerance, the pressure will be applied intermittently at first and then continuously for 90 seconds. | | | | For Group B:- Dry Needling + Passive stretching | The Dry needling technique for MTrPs was performed with ‘solid filiform needles’ (50 × .3 mm). |  | The exercise will require the participant to lie on their back. The skin that needs to be treated was cleaned with alcohol. Thumb and index finger were localised over the MTrp of the taut band, and the solid filiform needle was inserted into its plastic guide tube. |  | The tapping motion was used to insert the needle. was stopped after obtaining LTR. To cause a twitch in a muscle the needle was placed into the muscle bundle and moved in and out of the tissue, a process known as LTR (local twitch response). If there was no twitch after two or three stellate movements, the needle was stopped. | For Group C :- Ultrasound + Passive stretching Patients in the US group were given 1 MHz continuous conventional US treatment at a dose of 1.5 watts/cm2 for five minutes. The device draws intertwining circles on and around the trigger point in one-two seconds. DATA ANALYSIS:- Data will be collected through purposive sampling in a random manner and will further enquire and analyzed with appropriate statistical tools. | | | |