Low Back PainNCT05079893
Influence of Kinesiophobia on the Outcome of Chronic Low Back Pain Condition
An observational study of Low Back Pain, run by Gulf Medical University.
Trial summary
Though large body of evidence reported association between pain and kinesiophobia, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with Chronic lower back pain [CLBP]. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.
Who may be able to join
- Adults aged between 18 and 50 years.
- Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.
- Enough physical autonomy to participate in the physical activities required by the study.
Who cannot join
- Low back pain patients with radiculopathy, post fractures, stenosis and history of tumors, cauda equina syndrome and infection.
- Patient under antidepressive medication Inclusion Criteria for Asymptomatic subjects Age 18 years and above, Either gender.
- H/o previous lower back injury.
- H/o lower limb or trunk pathology.
- Presence of deformity, or condition that may alter motor control.
- History of inflammatory, infectious disease and malignancy in the spine
- Patient under anti depressive medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Kinesiophobia on Pain Intensity, Disability, Muscle Endurance and Position Sense in Subjects With Chronic Low Back Pain- A Case Control Study
Though large body of evidence reported association between pain and kinesiophobia, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with Chronic lower back pain [CLBP]. To the best of Investigator's knowledge, till date there is no studies assessing the relationship between kinesiophobia and endurance and position sense in subjects with CLBP. Therefore, the current study aims to compare the impact of kinesiophobia on lumbar extensor endurance, position sense in patient with CLBP and asymptomatic individuals.
Read the detailed description
Background:
Patients with chronic low back pain (CLBP) frequently present with kinesiophobia. Recent high quality studies reported a moderate to strong evidence of associations between a greater degree of kinesiophobia and greater levels of pain, greater levels of disability and poorer quality of life. However, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with CLBP.
Objective:
The primary aim of the study is to compare the impact of kinesiophobia on lumbar extensor endurance, position sense in patient with CLBP and asymptomatic individuals. Secondarily, to examine the association between kinesiophobia and lumbar extensor endurance, position sense, pain intensity and functional ability in patients with CLBP. Thirdly to assess the degree of association with various factors on CLBP, lumbar endurance and position sense.
Material and Methods:
This case-control study will have 200 patients with CLBP and 400 controls. Kinesiophobia will be assessed with Tampa Scale for Kinesiophobia. Lumbar endurance will be assessed with Soren's lumbar extensor test and lumbar position sense with neutral and target lumbar re-positioning tests. Secondarily, the pain intensity will be assessed with visual analog scale, functional ability with patient-specific Functional Scale in patients with CLBP. Kinesiophobia, lumbar endurance, and joint position sense will be compared between patients and controls. Kinesiophobia scores will be correlated with lumbar extensor endurance and proprioception joint position errors, pain intensity, and functional ability. Simple and multiple binary logistic regression will be used to determine crude and adjusted Odd's Ratio for kinesiophobia, lumbar position sense and kinesiophobia, lumbar endurance.
- Conditions
- Low Back Pain
- Being tested
- Case control study
- Keywords
- Low back pain, Kinesiophobia, position sense, Endurance
- Medical subject headings
- Low Back Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case control studyOther
Observational case control study
| Study group | Role | What they receive |
|---|---|---|
| Cases | The cases will be the patients suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician. Receives: Other: Case control study | |
| Controls | The controls will be the patients matched for age, sex, handedness who had no complaints of lower back pain Receives: Other: Case control study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Kinesiophobia.
Fear of movement/injury or reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK), a 17 self-reporting items with scores ranging from 17 (absence of fear) to 68 (highest fear). Tampa Scale for Kinesiophobia has been reported to have good reliability in patients with CLBP.
Measured: 5 MONTHS
Measuring Lumbar extensor endurance.
The subjects will be tested during a 1-hour session and will be asked to undergo a body weight dependent isometric back extension (Sorensen) test on a horizontal table
Measured: 5 MONTHS
Measuring Lumbar repositioning tests
Lumbar repositioning tests will be measured with dual inclinometer
Measured: 5 MONTHS
Secondary outcomes (2)
Measuring Pain
measured with Visual analog scale (VAS). The visual analogue scale consists of a 10-cm line, with the left extremity representing (absence of pain) and the right extremity indicating (great pain). Participants were asked to indicate in the scale their current level of pain, higher values being related to more intense pain.
Measured: 5 MONTHS
Measuring Functional ability
Functional ability will be measured using Patient-specific Functional Scale. Patients are asked to rate (on an 11-point scale) the current level of difficulty associated with each activity, where "0" represents "unable to perform" and "10" represents "able to perform at prior level
Measured: 5 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Praveen Kumar Kandakurthi, PhD, Study chair, College of Health Sciences, Gulf Medical UniversityDr. Watson Arulsingh Daniel Ragland, PhD, Principal investigator, College of Health Sciences, Gulf Medical UniversitySharad Patil, MPT, Principal investigator, Thumbay Physical Therapy and Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079893
- Sponsor's protocol ID
- IRB/COHS/FAC/03/May-2021
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kandakurti PK, de Sa Ferreira A, Calazans Nogueira LA, Arulsingh Daniel Ragland W, Patil SS. Influence of kinesiophobia on lumbar position sense in patients with chronic low back pain-a case-control study. J Back Musculoskelet Rehabil. 2025 Sep;38(5):1158-1164. doi: 10.1177/10538127251326152. Epub 2025 Mar 20.
PubMed 40111910Kandakurti PK, Arulsingh W, S Patil S. Influence of kinesiophobia on pain intensity, disability, muscle endurance, and position sense in patients with chronic low back pain-a case-control study. Trials. 2022 Jun 6;23(1):469. doi: 10.1186/s13063-022-06406-6.
PubMed 35668498
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Kinesiophobia on Pain Intensity, Disability, Muscle Endurance and Position Sense in Subjects With Chronic Low Back Pain- A Case Control Study
- ClinicalTrials.gov ID
- NCT05079893
- Acronym / sponsor ID
- IRB/COHS/FAC/03/May-2021
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Kinesiophobia, position sense, Endurance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Though large body of evidence reported association between pain and kinesiophobia, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with Chronic lower back pain [CLBP]. To the best of Investigator's knowledge, till date there is no studies assessing the relationship between kinesiophobia and endurance and position sense in subjects with CLBP. Therefore, the current study aims to compare the impact of kinesiophobia on lumbar extensor endurance, position sense in patient with CLBP and asymptomatic individuals.
Detailed description
Background:
Patients with chronic low back pain (CLBP) frequently present with kinesiophobia. Recent high quality studies reported a moderate to strong evidence of associations between a greater degree of kinesiophobia and greater levels of pain, greater levels of disability and poorer quality of life. However, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with CLBP.
Objective:
The primary aim of the study is to compare the impact of kinesiophobia on lumbar extensor endurance, position sense in patient with CLBP and asymptomatic individuals. Secondarily, to examine the association between kinesiophobia and lumbar extensor endurance, position sense, pain intensity and functional ability in patients with CLBP. Thirdly to assess the degree of association with various factors on CLBP, lumbar endurance and position sense.
Material and Methods:
This case-control study will have 200 patients with CLBP and 400 controls. Kinesiophobia will be assessed with Tampa Scale for Kinesiophobia. Lumbar endurance will be assessed with Soren's lumbar extensor test and lumbar position sense with neutral and target lumbar re-positioning tests. Secondarily, the pain intensity will be assessed with visual analog scale, functional ability with patient-specific Functional Scale in patients with CLBP. Kinesiophobia, lumbar endurance, and joint position sense will be compared between patients and controls. Kinesiophobia scores will be correlated with lumbar extensor endurance and proprioception joint position errors, pain intensity, and functional ability. Simple and multiple binary logistic regression will be used to determine crude and adjusted Odd's Ratio for kinesiophobia, lumbar position sense and kinesiophobia, lumbar endurance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Case control studyThe cases will be the patients suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician. |
| Controls | – | Other: Case control studyThe controls will be the patients matched for age, sex, handedness who had no complaints of lower back pain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.
Key inclusion criteria (3 listed)
- Adults aged between 18 and 50 years.
- Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.
- Enough physical autonomy to participate in the physical activities required by the study.
Key exclusion criteria (7 listed)
- Low back pain patients with radiculopathy, post fractures, stenosis and history of tumors, cauda equina syndrome and infection.
- Patient under antidepressive medication Inclusion Criteria for Asymptomatic subjects Age 18 years and above, Either gender.
- H/o previous lower back injury.
- H/o lower limb or trunk pathology.
- Presence of deformity, or condition that may alter motor control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case control studyObservational case control study | Other | Cases, Controls |
Primary outcome
Measuring Kinesiophobia.
Time frame: 5 MONTHS
Fear of movement/injury or reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK), a 17 self-reporting items with scores ranging from 17 (absence of fear) to 68 (highest fear). Tampa Scale for Kinesiophobia has been reported to have good reliability in patients with CLBP.
Measuring Lumbar extensor endurance.
Time frame: 5 MONTHS
The subjects will be tested during a 1-hour session and will be asked to undergo a body weight dependent isometric back extension (Sorensen) test on a horizontal table
Measuring Lumbar repositioning tests
Time frame: 5 MONTHS
Lumbar repositioning tests will be measured with dual inclinometer
2 secondary outcomes
Measuring Pain
Time frame: 5 MONTHS
Measuring Functional ability
Time frame: 5 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 40111910Kandakurti PK, de Sa Ferreira A, Calazans Nogueira LA, Arulsingh Daniel Ragland W, Patil SS. Influence of kinesiophobia on lumbar position sense in patients with chronic low back pain-a case-control study. J Back Musculoskelet Rehabil. 2025 Sep;38(5):1158-1164. doi: 10.1177/10538127251326152. Epub 2025 Mar 20.
- Derived from this study: PubMed 35668498Kandakurti PK, Arulsingh W, S Patil S. Influence of kinesiophobia on pain intensity, disability, muscle endurance, and position sense in patients with chronic low back pain-a case-control study. Trials. 2022 Jun 6;23(1):469. doi: 10.1186/s13063-022-06406-6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Praveen Kumar Kandakurthi, PhD study chair
College of Health Sciences, Gulf Medical University
Dr. Watson Arulsingh Daniel Ragland, PhD principal investigator
College of Health Sciences, Gulf Medical University
Sharad Patil, MPT principal investigator
Thumbay Physical Therapy and Rehabilitation Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Gulf Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Praveen Kumar Kandakurthi, PhD (+971 6 7431333 ext. 1386, dean.coahs@gmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Kinesiophobia. (time frame: 5 MONTHS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.