| CTRI Number |
CTRI/2024/11/077074 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Impact of Combined TENS and Myofascial Release Therapy for Young Women with Cervicogenic Headaches: A Pilot Study |
|
Scientific Title of Study
|
Evaluating the Efficacy of Transcutaneous Electrical Nerve Stimulation and Myofascial Release among Young Females with Cervicogenic Headache- A pilot feasibility 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 |
Dr Sumera Khan |
| Designation |
Associate Professor |
| Affiliation |
galgotias university |
| Address |
room no- E004 Department of Physiotherapy,School of Allied Health Science, Galgotias University,Opposite Buddha International Circuit Gautam Buddha Nagar
UTTAR PRADESH
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
917827777195 |
| Fax |
|
| Email |
Sumera.khan@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumera Khan |
| Designation |
Associate Professor |
| Affiliation |
galgotias university |
| Address |
room no- E004 Department of Physiotherapy,School of Allied Health Science, Galgotias University,Opposite Buddha International Circuit Gautam Buddha Nagar
UTTAR PRADESH
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
917827777195 |
| Fax |
|
| Email |
Sumera.khan@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Soni Singh |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
room no- E004 Department of Physiotherapy,School of Allied Health Science, Galgotias University,Opposite Buddha International Circuit Gautam Buddha Nagar
UTTAR PRADESH
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
916397504466 |
| Fax |
|
| Email |
physiotherapistsonisingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University, Opposite Buddha International
Circuit Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias University, Opposite Buddha International
Circuit Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Sumera Khan |
Galgotias University |
Room no E004, Department of Physiotherapy, School of Allied Sciences , Galgotias University, Plot no 2 , sector 17A , Opposite Buddh International Circuit, GreaterNoida , G.B Nagar, Uttar Pradesh, India 203201
Gautam Buddha Nagar
UTTAR PRADESH |
7827777195
sumera.khan@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| departmental research committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TENS |
or TENS treatment of cervicogenic headaches in females, adhesive electrodes are placed on the cervical and upper back muscles. A low-frequency current is applied for 20-30 minutes per session to reduce pain and stimulate endorphin release. |
| Intervention |
TENS with MFR |
Myofascial Release (MFR):
MFR will be applied to the cervical and upper back regions to release muscle tightness and fascial restrictions. The therapist will use sustained pressure on trigger points for 20-30 minutes to alleviate pain and improve mobility.
Transcutaneous Electrical Nerve Stimulation (TENS):
TENS will be applied using adhesive electrodes placed on the cervical and upper back muscles. A low-frequency current will be used for 20-30 minutes per session to reduce pain and enhance endorphin release.
Combined Treatment Protocol:
Each session will include both MFR (20-30 minutes) followed by TENS therapy (20-30 minutes) to provide both immediate pain relief and address the underlying musculoskeletal dysfunction.
Frequency and Duration:
The combined treatment will be given 3 times per week for 4 weeks, with each session lasting 40-60 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Gender: Only females will be included in the study.
2. Age Range: Participants aged between 20-40 years.
3. Diagnosis: Clinically diagnosed with cervicogenic headaches as per standardized diagnostic criteria.
4. Duration of Symptoms: Suffering from cervicogenic headaches for a minimum of 3 months.
5. Pain Intensity: Baseline headache intensity of moderate to severe on the visual analog scale (VAS).
6. Willingness to Participate: Participants must provide written informed consent and agree to adhere to the treatment protocol and follow-up schedule.
7. No Recent Treatment: Participants must not have received any physiotherapy, TENS, or manual therapy interventions in the last 3 months.
|
|
| ExclusionCriteria |
| Details |
1. Other Headache Types: Exclude participants diagnosed with migraines, tension-type headaches, or any other primary headache disorders.
2. Neck or Spine Surgery: Exclusion of individuals with a history of cervical spine surgery or other surgical interventions.
3. Neurological Disorders: Those with neurological conditions like multiple sclerosis or epilepsy that could influence treatment outcomes.
4. Chronic Pain Syndromes: Exclude individuals diagnosed with fibromyalgia, rheumatoid arthritis, or other systemic musculoskeletal or autoimmune disorders.
5. Pregnancy: Pregnant women or those planning to become pregnant during the study period.
6. Pacemaker or Electrical Implants: Exclude participants with pacemakers or other implanted electrical devices that could interfere with TENS therapy.
7. Psychiatric Conditions: Severe psychiatric disorders (e.g., major depressive disorder, schizophrenia) that might impact the perception of pain or adherence to treatment protocols.
8. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Intensity (VAS): Measure reduction in pain severity using the Visual Analog Scale (VAS).
Headache Frequency: Track the number of headache episodes per week.
Cervical Range of Motion (ROM): Assess improvements in neck mobility.
Patient Global Impression of Change (PGIC): Evaluate overall patient-reported improvement after treatment. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index (NDI): Measure disability caused by neck pain and its impact on daily activities.
Quality of Life (SF-36 or EQ-5D): Assess changes in overall physical, emotional, and social well-being.
Muscle Tension: Evaluate reduction in muscle tightness through palpation.
Psychological Impact (DASS or STAI): Measure changes in anxiety, stress, and depression levels. |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/11/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 pilot feasibility trial investigates the effectiveness of a combination therapy using Transcutaneous Electrical Nerve Stimulation (TENS) and Myofascial Release (MFR) in young females with cervicogenic headache (CGH). CGH, a secondary headache originating from the cervical spine, can result in chronic discomfort, limited neck mobility, and reduced quality of life. While TENS is commonly used for pain relief by delivering low-voltage electrical currents to stimulate nerves, MFR is a manual technique aimed at releasing muscle tightness and improving tissue flexibility. Both therapies are non-invasive and are widely used for pain management, but limited research has examined the synergistic effects of using them together.
The primary objective of this study is to assess the feasibility, safety, and initial therapeutic outcomes of combining TENS and MFR in managing CGH. Outcome measures include the frequency, intensity, and duration of headaches, as well as functional capacity and overall quality of life. By evaluating participant adherence, tolerance, and any adverse effects, this study will determine the practicality of conducting a larger randomized controlled trial on this combination therapy.
Preliminary findings could reveal whether TENS and MFR offer complementary effects that enhance pain management, allowing young females with CGH to experience improved physical function and daily comfort. This research contributes to expanding non-pharmacological treatment options for CGH, emphasizing personalized and accessible interventions. If successful, the study could pave the way for more comprehensive approaches in treating CGH, providing an evidence base for integrating TENS and MFR into clinical practice for this demographic. |