A clinical trial to study the effect of two therapies - Marma Chikitsa and Conventional Physiotherapy in patients with Cervical Spondylosis.
- Conditions
- Ankylosing spondylitis of cervicalregion. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (KEVALAVATA),
- Registration Number
- CTRI/2021/04/032983
- Lead Sponsor
- DR HIRENKUMAR BALVANTBHAI MISTRY
- Brief Summary
The research studyentitled “A clinical evaluationof *Marma Chikitsa* & Conventional Physiotherapy in the management of *Grivasandhigata* *Vata* w.s.r to CervicalSpondylosis– A Randomized Controlled Trial†was aimed to evaluate andcompare the efficacy of *Marma Chikitsa* & Conventional Physiotherapyin the management of *Grivasandhigata* *Vata* w.s.r to CervicalSpondylosis. This trial was summarized in review of literature, includingAyurvedic literature and modern literature of *Grivasandhigata* *Vata*(Cervical Spondylosis) and literature of *Marma Chikitsa.*
Clinical studystats the open labelled comparative clinical study of 168 clinical cases of Cervical Spondylosis dividedinto two groups according computer-generated randomization chart. Total 180cases were screened throughout the study with cervical or neck pain, amongwhich total 168 cases were falling in the study criteria. 06 cases were droppedout and 162 cases completed the course of treatment and follow up as mentionedin study. In Group-A (n=94):One session of *Marma Chikitsa* was given in morning hours for the periodof 14 days. In Group-B (n=71): Physiotherapy – Isometric and stretching exercise -10 repetition of eachexercise in a day for 14 days after completion of treatment follow up was doneby every fortnight for 1 month in both groups. Patients were assessed forrelief in sign and symptoms adopting gradation method. Follow up period was onemonth after completion of the treatment to see any complication, recurrence andcondition of the patients. Allthe cases were screened for essential haematology, bio-chemical andradiological investigations prior their enrolment for the study. The effect ofthe treatment was assessed on the basis of relief in Pain, stiffness, giddiness,tingling and numbness, loss of sensation and NDI Score where subjectivecriteria were assessed by VAS scale and gradation. Ranges of movements (ROM),were considered as the objective parameters. The ROM namely cervical flexion, cervicalextension, left and right lateral flexion, rotation towards left and right wererecorded according to the actual values of goniometric readings. The observedresults in the study were subjected to statistical calculation to derive finalconclusion.
Discussion onstudy was made on demographic observations and clinical findings. Conclusion ofclinical study suggest that both the groups treatment protocol have shown highlysignificant difference was observed in *Grivasandhishula*(pain), *Grivasandhistambha* (Stiffness), NDI score and ROM (Range ofMotion). There was increase in ROM as well as relief in pain, decreasedstiffness as a result of increase ROM from before treatment to after treatmentas a result of *Marma* *Chikitsa* and Physiotherapy.Because ofthat neck disability was reduced compare to before and result of NDI score wasimproved. Non-significant difference was observed in comparative effect oftherapy in all laboratory investigation. Thus, it declares that thealternative hypothesis is accepted and the null hypothesis is rejected. i.e., *Marma Chikitsa* is moreeffective than conventional physiotherapy in the management of *GrivasandhigataVata* w.s.r. Cervical Spondylosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- 1.Patients suffering from Grivasandhigata Vata (Pain, Stiffness in cervical region or upper arm and Restricted range of motion of Cervical region (ROM)) 2.Duration of Cervical Spondylosis upto 6 months 3.Patients with controlled diabetes mellitus (FBS: <140mg/dl, PPBS :< 180mg/dl).
- 4.Patients with controlled Hypertension (BP <140mmHg) 5.Patients willing to undergo trial.
- 1.Age below 25 years and above 65 years.
- 2.Not willing to undergo trial 3.If Pain VAS score > 5 4.Tuberculosis of cervical spine & malignancy 5.Fracture related to cervical spine, significant radiculopathy.
- 6.Other diseases like cardiac diseases, renal diseases and endocrine diseases, severe Anemia, and Malignancy, 7.Patients of uncontrolled Diabetes mellitus (FBS: >140mg/dl, PPBS:>180mg/dl) 8.Patients with uncontrolled Hypertension (BP >140mmHg) 9.Pregnant female.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prasarana Akunchana Pravritti Savedana (painful movement of cervical) The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Headache The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Subjective criteria: The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. The following symptoms will be assessed on the basis of gradation. The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Grivasandhi Shoola (cervical pain) The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Associate symptoms: The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Grivasandhi Stambha (Stiffness in cervical region) The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Loss of sensation The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Giddiness The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day. Tingling sensation The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day.
- Secondary Outcome Measures
Name Time Method Objective criteria: Range of movement (ROM) will be measured with Goniometer.
Trial Locations
- Locations (1)
INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), JAMNAGAR
🇮🇳Jamnagar, GUJARAT, India
INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), JAMNAGAR🇮🇳Jamnagar, GUJARAT, IndiaDR HIREN B MISTRYPrincipal investigator9427637420drhirenmistry@gmail.com