Skip to content

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) pain

HEALEN STUDY-A prospective, single centre, open label, randomised clinical study to evaluate and compare clinical efficiency of Healen Therapy (App & Cloud services) and existing modalities in subjects with various joint (s) pain - HEALEN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030726
Enrollment
90
Registered
2021-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M255- Pain in joint

Interventions

Intervention1: Healen Therapy App and Cloud services: 1 month 2 month 3 month HEALEN is a software application which will capture data which are collected from participants. The data are end to end e

Sponsors

Prima Prehab HealthTec Inc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Comparison of functional improvement in patients assessed through Orebro Musculoskeletal Pain Screening Questionnaire (OMSQ) (Short) in each cohort Anatomical Region specific PROMS Comparison of Mean change in pain intensity score assessed through NPRS (Numeric Pain Rating Scale) in each cohort Comparison of requirement of medication in each cohortTimepoint: Day 0 Day 28 Day 56 Day 84

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactMohammad Azharuddin

Prima Prehab HealthTec Inc (Indian Subsidiary: Aktivortho Pvt Ltd)

karan.jaggi@healen.com9654601958

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026