| CTRI Number |
CTRI/2023/03/050601 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
kinesophobia in chronic non specific low back pain |
|
Scientific Title of Study
|
Prevalence of kinesophobia and relation with pain characteristics in chronic non-specific low back pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oshmi Pal |
| Designation |
Post Graduate Student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM college of Physiotherapy Manjushree Nagar sattur Dharwad Karnataka 580009 India
Dharwad KARNATAKA 580009 India |
| Phone |
9826029193 |
| Fax |
|
| Email |
oshmi96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Oshmi Pal |
| Designation |
Post Graduate Student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM college of Physiotherapy Manjushree Nagar sattur Dharwad Karnataka 580009 India Dharwad KARNATAKA 580009 India |
| Phone |
9826029193 |
| Fax |
|
| Email |
oshmi96@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr shweta kulkarni |
| Designation |
Professor |
| Affiliation |
SDM college of physiotherapy |
| Address |
SDM college of physiotherapy OPD no 5 Department of orthopaedics physiotherapy. manjushreenagar sattur Dharwad Karnataka India.
Dharwad KARNATAKA 580009 India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of physiotherapy orthopaedics department |
|
|
Primary Sponsor
|
| Name |
Oshmi Pal |
| Address |
SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India |
| 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 |
| Oshmi Pal |
SDM college of medical science and hospital |
SDM college of physiotherapy OPD no-5 Department of orthopaedics
physiotherapy. manjushreenagar sattur
Dharwad
KARNATAKA
580009
India Dharwad KARNATAKA |
9826029193
oshmi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic non specific low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with the type of low back pain Chronic (more than 3 months of duration),
Non-specific and Non- radicular diagnosed by orthopaedician.
2. Age group between18-65 years.12.
3. Subjects of either gender
4. Subjects who agree and are ready to sign the consent form |
|
| ExclusionCriteria |
| Details |
1. Subjects with acute low back pain and with a known cause of Radicular pain.
2. Subjects with an age group less than 18 and more than 65 years.12
3. Serious or progressive neurological deficits.
4. Presence of co-existing chronic pain conditions other than low back pain (eg.
Fibromyalgia)
5. Symptoms underlying conditions such as (tumor osteoporosis, spinal canal
stenosis, compression fracture, structural deformities of spine.
inflammations/infectious disease, lumbar radiculopathy, ankylosing spondylosis,
cauda equina syndrome)
6. Sensory loss of skin.
7. Skin inflammation or edema in the lower back
8. Pregnant or until 1 year postnatal
9. Epilepsy, cancer, arthritis (except osteoarthritis), major psychiatric disorders.
10. Awaiting surgery or having had surgery in the past.
11. Individuals not ready to sign the consent form |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
vas scale
tampa scale |
baseline (we are doing subject assessment only once) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain catastrophizing scale
SF 36 questionnaire
Pressure algometer
Self-efficacy scale
Recognize app for back |
baseline (we are doing subject assessment only once) |
|
|
Target Sample Size
|
Total Sample Size="262" Sample Size from India="262"
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)
|
16/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to a few studies, they have commented that the fear of movement (kinesophobia) is one of the determinants of acute pain developing into chronic pain. Another study has concluded that subjects who did not recover in two months developed chronic pain and fear of pain was the most predicting factor of chronic pain. Also, another study mentioned that pain-free subjects when assessed for fear had high chances of developing musculoskeletal pain in the future (vlaeyen) literature also states that among various other psychological factors, kinesophobia is positively associated with pain intensity, disability, in chronic low back pain. But the limitations of these studies were that the sample size was less, the population was heterogeneous and they were not able to find the cause and effect relationship between the pain and other factors as the study was a cross-sectional also studies have stated that objective outcome measures should be used as all of these studies included the self-reported measures and most of these studies were conducted abroad, so the results couldn’t be generalized to all the populations. There exists a strong need to find out the prevalence of strong predictors of chronic pain that as kinesophobia and also to find out the correlation between kinesophobia and characteristics of chronic pain using objective methods like pressure algometer (pain pressure threshold) and laterality test in chronic nonspecific low back pain as it is more prevalent in India (60%). Hence this study aims to find out the prevalence of kinesophobia and relation with pain characteristics in chronic non-specific low back pain. |