A randomised clinical study to evaluate and compare clinical efficiency of Healen Therapy (App & Cloud services) and existing modalities in subjects with various joint(s) pai
- Conditions
- Health Condition 1: M255- Pain in joint
- Registration Number
- CTRI/2021/01/030726
- Lead Sponsor
- Prima Prehab HealthTec Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Male or Female subjects of 18-65 years of age
Chronic Joint pain/ stiffness (Neck, Back , Shoulder & Knee Pain) for at least 12 weeks
Intensity of the average pain should be � 4 on the numeric pain rating scale (NPRS) in the last week
Possession of a smart phone and willingness to do provide required study data through a smart phone application (App)
Physical and Mental ability to participate in the study
Willingness to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and subject diaries provided by a smart phone application
Working knowledge of English
Able to give written informed consent
Joint pain caused by a known malignant disease
Joint pain caused by trauma
Known rheumatic disorder
Subjects with Blood Dyscrasias
Subjects using Anticoagulant therapy for any disease
History of surgical intervention in last 6 months
Known neurological symptoms e.g. radicular symptoms because of prolapsed vertebral disc
Regular intake of analgesics ( >1x per week) because of additional diseases
Intake of centrally acting analgesics
Known severe acute or chronic disorder, that do not allow participation in the therapy
Known alcohol or substance abuse
Participation in another clinical trial in last 3 months before the study and parallel to the study
Conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of functional improvement in patients assessed through Orebro Musculoskeletal Pain Screening Questionnaire (OMSQ) (Short) in each cohort <br/ ><br>Anatomical Region specific PROMS <br/ ><br>Comparison of Mean change in pain intensity score assessed through NPRS (Numeric Pain Rating Scale) in each cohort <br/ ><br>Comparison of requirement of medication in each cohortTimepoint: Day 0 <br/ ><br>Day 28 <br/ ><br>Day 56 <br/ ><br>Day 84
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable