| CTRI Number |
CTRI/2024/07/071697 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical Study On The Effect of Dry Cupping And Isometric Neck Exercise In Cervical Spondylosis |
|
Scientific Title of Study
|
A Comparative Clinical Study On The Effect of Hijama-Bila-Shart (Dry Cupping) And Isometric Neck Exercise in 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 |
Fasihuddeen |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj
Allahabad UTTAR PRADESH 211016 India |
| Phone |
9651918533 |
| Fax |
|
| Email |
fasihuddeen111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Nusrat Parveen |
| Designation |
Professor |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj
Allahabad UTTAR PRADESH 211016 India |
| Phone |
7906813040 |
| Fax |
|
| Email |
nusratparveen12755@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Fasihuddeen |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj
Allahabad UTTAR PRADESH 211016 India |
| Phone |
9651918533 |
| Fax |
|
| Email |
fasihuddeen111@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital Prayagraj 211016,Uttar Pradesh,India |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College Himmatganj Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj Uttar Pradesh
211016
India |
| 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 |
| Dr Fasihuddeen |
State Unani Medical College and Hospital |
Department of Ilaj-Bit-Tadbeer,room no 2 ground floor Allahabad UTTAR PRADESH |
9651918533
fasihuddeen111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, State Unani Medical College Prayagraj |
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-Bila-Shart (Dry Cupping) |
Size of cups- medium size (5.5 cm diameter)
No. of cups- 04
Location- 2 on Kahil (Interscapular region), 2 on Mankibain (Suprascapular region)
Duration of intervention- 10-15 minutes in each sitting
Duration of Treatment protocol- intervention will be given on alternate day for 3 weeks
Follow up- Clinical assessment during treatment/ therapy weekly. |
| Comparator Agent |
Isometric Neck Exercise |
-For 6 consecutive days in a week for 21 days.
-Three times/ day (morning, afternoon, evening).
-Each set consisted of 6 movements.
-Each movement hold for 10 sec, and repeating each movement 5 times after a 5-sec rest
between each of them.
Each set of neck isometric strengthening exercises comprised 6 movements, as follows:
1. Cervical flexion: Lean the neck slightly forward, place palm of both hands-on forehead and
push the head towards the hands while resisting the movement with hands.
2. Cervical extension: Keep the neck straight, put palm of both hands behind the head, push
the head backwards the hands while resisting the movement with hands.
3. Right Lateral Flexion: Keep the neck straight, put palm of right hand on right side of the
head; push the head towards the hand to bring head down to the right shoulder while pushing
the hand vice versa.
4. Left Lateral Flexion: Keep the neck straight, put palm of left hand on left side of the head;push the head towards the hand to bring head down to the left shoulder while pushing the hand
vice versa.
5. Right Rotation: Put palm of right hand on right side of face; rotate the head slightly to the
right while resisting the movement with hand.
6. Left Rotation: Put palm of left hand on left side of face, rotate the head slightly to the left
while resisting the movement with hand. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Willing to participate in the study.
-Clinically and radiologically diagnosed patients of
Waja-ur-raqaba (Cervical spondylosis).
-No apparent spinal deformity like- Kyphosis,
scoliosis, Lordosis etc. |
|
| ExclusionCriteria |
| Details |
-Age less than 20 years and more than 60 years.
-Previous history of neck trauma, cervical
fracture or surgery.
-History of congenital spinal abnormality, spinal
tumour and cancer.
-Uncontrolled Diabetes mellitus and Hypertension.
-Pregnant and lactating women.
-Patients taking analgesic drugs, steroidal
treatment and Hormonal therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VAS (Visual Analogue Scale)
|
0,7,14,21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.VAS (Visual Analogue Scale)
2.NPQ (Northwick Park Neck Pain
Questionnaire)
3. Quality Of Life Index |
0,21 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
12/08/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
.Waja-ur-Raqaba (Cervical spondylosis) is a chronic degenerative process of the vertebral column characterized by pain in neck, degenerative changes in intervertebral disc and osteophyte formation. Most common degenerative changes are seen in C5-C6 followed by C6-C7 and C4-C5. About 10 million persons per year affected in India alone. The incidence of neck pain in adults is 25-50% per year. Prevalence of Cervical Spondylosis is similar in both sexes although degree of severities is greater in males. It is most common spine dysfunction in elderly people; the highest prevalence is in the age group from 45 to 60 years old. Spondylotic changes of the cervical spine on radiographic imaging remain asymptomatic with 25% of individuals under the age of 40, 50% of individuals over the age of 40, and 85% of individuals over the age of 60 showing some evidence of degenerative changes. It may develop earlier due to life style changes like prolong sitting, driving, travelling and lack of exercise etc. Cervical spondylosis can be described as a result of degeneration of the intervertebral disc, formation of osteophytes,ossification of the posterior longitudinal ligament and hypertrophy of the ligamentum flavum. The symptoms arise in case of cervical spondylosis are neck pain, stiffness, resulting in limitation of movement and numbness, weakness in arm, hand, and fingers. In Modern System of Medicine Cervical spondylosis is treated by use of NSAIDS (Non steroidal anti-inflammatory drugs), corticosteroids, cervical epidural steroid injection, surgery and certain physiotherapy modalities like isometric neck exercise, TENS (Transcutaneous Electrical Nerve Stimulation), traction and cervical collar etc. Though, the use of NSAIDS and corticosteroids provide significant improvement in symptoms of Cervical spondylosis on short term basis, but their prolong use may induce a number of side effects. Similarly, most of the patients avoid surgery due to complications associated with it. As far as concerned with various regimens of physiotherapy like isometric neck exercise, TENS, Ultrasound, Superficial thermotherapy etc, definitely they relieve the symptoms of Cervical spondylosis, but not up to the mark of satisfaction. Hence, there is a dire need to develop a safe and effective mode of treatment for the management of Waja-ur-Raqaba (Cervical spondylosis). In Unani system of medicine, Waja-ur-Raqaba is not clearly mentioned in classical text, but most of the eminent physicians used “Waja-ul-mafasil†to represent all types of joint pain, and also named them accordingly like Niqras (Gout), Waja-ul-Warik (Ischial pain), Irqunnasa (Sciatica), Waja-ul-Rakbah (Knee pain) etc. Similarly, when Wajaul mafasil occurs in fuqrat-e-unuq and causes neck pain, it is known as Waja-ur-Raqaba (Cervical spondylosis), because here waja stands for pain and raqaba stands for neck. As far as the treatment of Waja-ul-mafasil is concerned, since ancient times Unani physicians treated this ailment successfully with various drugs & regimens including Hijama-bila-Shart (Dry Cupping), Dalk (Massage), Riyazat (exercise), Takmeed (Fomentation), Nutool (Irrigation) etc. Among them Hijama-bila-Shart is one which is commonly prescribed to diversion of Mawad-e-Fasida and to provide relief to the patient of Waja-ul-Mafasil. Hence, keeping the above view in mind I have decided to conduct a comparative study entitled as “A Comparative clinical study on effects of Hijama-Bila-Shart (dry cupping) and isometric neck exercise in Waja-ur-Raqaba (Cervical spondylosis). |