| CTRI Number |
CTRI/2020/04/024650 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between pain acceptance and self reported quality of life in subjects with musculoskeletal pain |
|
Scientific Title of Study
|
ASSOCIATION BETWEEN PAIN ACCEPTANCE AND SELF REPORTED QUALITY OF LIFE IN SUBJECTS WITH CHRONIC MUSCULOSKELETAL PAIN : A CROSS-SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cassindra Cardoz |
| Designation |
postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Physiotherapy, Manjushreenagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
7507284737 |
| Fax |
|
| Email |
ccardoz77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Cassindra Cardoz |
| Designation |
postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Physiotherapy, Manjushreenagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
7507284737 |
| Fax |
|
| Email |
ccardoz77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant B Mukkannavar |
| Designation |
Professor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Physiotherapy, Manjushreenagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9036981180 |
| Fax |
|
| Email |
drprashantmb@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Physiotherapy, Manjushreenagar, Sattur, Dharwad |
|
|
Primary Sponsor
|
| Name |
Cassindra Cardoz |
| Address |
SDM College of Physiotherapy, Manjushreenagar, Sattur, Dharwad, Karnataka
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| Cassindra Cardoz |
Shree Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital |
Orthopedic Physiotherapy Department, OPD no. 5,
Shri Dharmasthala Manjunatheshwara University of Medical Sciences and Hospital
Dharwad
KARNATAKA |
7507284737
ccardoz77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM INSTITIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age group between 18 to 60 years of age
2. Duration of pain should be greater than 3 months
3. Subjects belonging to either gender
4. Subjects willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Previous participation in Psychotherapy programs
2. Subjects on pain relieving medications
3. Subjects with Neuropathic pain
4. Subjects with post-surgical or post-traumatic pain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Chronic Pain Acceptance Questionnaire
2.WHOQOL-BREF |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nordic Musculoskeletal Questionnaire- Extended
Tampa Scale of Kinesiophobia
Pain Catastrophizing Scale |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="438"
Sample Size from India="438"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain
acceptance, as a psychological component, has a role in chronic pain especially
in chronic musculoskeletal pain. The role of acceptance in determining the quality of life in chronic
low back pain cases was studied and it
was found that acceptance was found to be positively associated with
self-reported quality of life. Furthermore, the authors concluded
that activity engagement and pain willingness may influence different subjective
interpretations of quality of life in each chronic pain population, and this
should be systematically investigated. Although this study focused on subjects
with low back pain, no other study has found the association between pain
acceptance and quality of life in other musculoskeletal pain conditions.
Therefore, a need arises to confirm the findings of the association of pain
acceptance with self-reported quality of life in subjects with chronic
musculoskeletal pain. Understanding the role of pain acceptance on the quality
of life of individuals is imperative so that effective acceptance based rehabilitation
programs are introduced and directed towards the management of chronic
musculoskeletal pain. |