| CTRI Number |
CTRI/2025/07/091492 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relieving Neck Pain: A Study of Fire Cupping vs. TENS Therapy |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the effect of Hijama-bil-Nar and Transcutaneous electrical nerve stimulation in the management of Waja-ur-Raqaba (Cervical spondylosis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rubina Saifi |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and HAHRDM hospital himmatganj Prayagraj, Uttar Pradesh Pin Code 211016 |
| Address |
Department of Ilaj-bit-tadbeer State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8882031610 |
| Fax |
|
| Email |
saifiruvina1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bushra Aftab |
| Designation |
Reader |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Ilaj-bit-tadbeer State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279747882 |
| Fax |
|
| Email |
drbushraaftab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rubina Saifi |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Ilaj-bit-tadbeer State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8882031610 |
| Fax |
|
| Email |
saifiruvina1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
State Unani Medical College Prayagraj Uttar Pradesh |
| Address |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rubina Saifi |
State Unani Medical College and HAHRDM Hospital |
Department of Ilaj-Bit-Tadbeer State Unani Medical College Himmatganj prayagraj uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH |
8882031610
saifiruvina1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama-bil-Nar |
Size of cups- 2 no. (2 inches in diameter)
No. of cups- 04
Location- 2 cups on Kahil (interscapular region) and 2 cups on mankibain (Suprascapular region)
Duration of intervention- 10 minutes
No. of sitting- Total 14 sittings will be given (2,4,6,8,10,12,14,16,18,20,22,24,26 and 28th day)
Duration of treatment protocol- 4 weeks
Follow up- on 7,14,21 and 28th day. |
| Comparator Agent |
TENS (Transcutaneous electrical nerve stimulation) |
Location- Electrodes of TENS will be placed along the dermatomes of cervical nerves.
Site- 2 electrodes on suprascapular region, 1 electrode on cervicothoracic space and 1 electrode on interscapular space.
Duration of Intervention- 10 minutes
Frequency- 100 Hz
Intensity- 12-30 mA
No. of sitting- Total 14 sittings will be given (on 2,4,6,8,10,12,14,16,18,20,22,24,26 and 28th day)
Duration of treatment protocol- Intervention will be given on alternate day for 4 weeks.
Follow up- on 7,14,21 and 28th day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to participate in the study.
2. Both genders.
3. Age between 20 – 60 years.
4. Clinically or radiologically diagnosed patients of Waja-ur-Raqaba (Cervical spondylosis).
5. Patients having mild to moderate pain (VAS Score = 1-7) |
|
| ExclusionCriteria |
| Details |
1. Age less than 20 years and more than 60 years.
2. Previous history of neck trauma, cervical fracture or surgery.
3. History of congenital spinal abnormality, spinal tumor and cancer.
4. Uncontrolled Diabetes mellitus.
5. Patients taking analgesic drugs, steroidal treatment in past one week.
6. Epilepsy.
7. Known cases of Cardiac diseases e.g. Coronary artery diseases, Arrythmias, Cardiac pacemaker etc.
8. Prosthesis e.g. metal rods, screw etc.
9. Sensitive skin.
10. Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. VAS (Visual Analog Scale)
2. NPQ (Northwick Park Neck Pain Questionnaire) |
0,7,14,21 and 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of quality of life by Short form-36(SF-36) Questionnaire |
0 and 28th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2025 |
| 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="6"
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
|
In Modern The term cervical spondylosis denotes the osteoarthritis in the cervical spine characterized by chronic disc degeneration in the cervical vertebrae and osteophytes formation. The most common evidence of degeneration is found at C5-C6 followed by C6-C7 and C4-C5. It is characterized clinically by pain in the neck with or without radiation; tingling, numbness, congestion, compression of nerve and paresthesia, headache may be seen in occipital region and often described as spreading up over the back of the head to the frontal region. Radiological changes of cervical spondylosis are frequently found in apparently healthy individuals above the age of 50.In Unani Medicine Waja-ur-Raqaba (Cervical spondylosis) as such is not clearly mentioned in the authentic Unani literature, but all the Renowned Unani Scholars described the joint pain under the context of term Waja-ul-Mafasil. It comprises all variety of joint pain like Niqras (Gout), Waja-ul-Warik (Ischial pain), Waja-ul-Aqab (Ankle pain), Irqunnasa (Sciatica), Waja-ul-Rakbah (Knee pain) etc. Most of the Unani physicians clearly explain the aetiopathogenesis of Waja-ul-Mafasil on the basis of quantitative and qualitative derangement of akhlat (humours).only temperament of humours gets disturbed causing just functional disturbance of articular surfaces, it is of short duration, while in case of Waja-ul-Mafasil maddi, there is qualitative and quantitative changes in the humours (Akhlat) take place in the joint spaces.Hijamah-bil-Nar is one which is commonly prescribed to diversion mawad-e-fasida (morbid humours) and to provide relief to the patient of Waja-ul-Mafasil. It is used for Imala-e-Mawad (Diversion of morbid humours) from affected part and relieves pain, resolves inflammation, alleviated congestion, produces localize heat by increasing local blood circulation and diversion of morbid matter, reduces pain. TENS is widely used to provide relief in cervical spondylosis, tingling sensation, numbness, neural pain. Hence, keeping the above facts in mind, I plan a study to compare the effect of Hijama-bil-Nar with TENS in the management of Waja-ur-Raqaba entitled as “A randomized comparative clinical study to evaluate the effect of Hijama-bil-Nar and Transcutaneous electrical nerve stimulation in Waja-ur-Raqaba (Cervical spondylosis). |