- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06611722
The Differences in the Psychological States of Patients with Different Chronic Hip Pain
September 24, 2024 updated by: ChunBao Li
A Clinical Retrospective Cross-sectional Study of the Differences in the Psychological States of Patients with Different Chronic Hip Pain
Nowadays, studies related to the psychological state of patients with chronic hip pain are still limited, and there is a lack of research on the characteristics of the psychological state of patients with chronic soreness from different pain sources.
The goal of this retrospective cross-sectional study was to reveal differences between the psychological states of chronic hip pain patients with different pain sources.
The main question it aims to answer is whether there are differences in psychological states among hip pain patients with intra-hip pain, extra-hip pain, and intra-hip combined with extra-hip pain.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- General Hospital of the Chinese People's Liberation Army
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with chronic hip pain who visited the hip joint specialist outpatient clinic of the PLA General Hospital were included in the study.
The diagnosis was made by the same docter based on clinical and radiological examinations, with a clear diagnosis of hip disease.
Patients were divided into three groups according to the source of pain: intra-articular pain group, extra-articular pain group, and intra-articular combined extra-articular pain group.
Intra-articular hip pain encompasses a range of conditions, including femoral acetabular impingement (FAI) and labral damage within the hip joint.
Extra-articular hip pain encompasses conditions such as trochanteric bursitis and gluteal fasciitis.
Combined hip pain represents a combination of both of these etiological factors.
Description
Inclusion Criteria:
- The subject must be at least 16 years old and of sound mind;
- Chronic hip pain persisting for a duration exceeding 3 months.
Exclusion Criteria:
- Previous mental illness and cognitive impairment;
- Other serious illnesses such as heart failure, respiratory failure, malignant tumours, severe trauma and other serious illnesses;;
- Chronic pain lasting for more than 3 months in other parts of the body;;
- Use of prescribed opioid drugs exceeding 60 mg morphine equivalent per day or steroid analgesics.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
intra-articular hip pain group
|
Assessment of Pain Sources: Patients are grouped based on intra-articular, extra-articular, or combined intra- and extra-articular hip pain.Psychological Assessment: Depression and anxiety are assessed using standardized questionnaires (e.g., BDI for depression, SAS for anxiety).Functional Assessment: Joint function and pain are evaluated using clinical and patient-reported outcome measures.
|
|
extra-articular hip pain group
|
Assessment of Pain Sources: Patients are grouped based on intra-articular, extra-articular, or combined intra- and extra-articular hip pain.Psychological Assessment: Depression and anxiety are assessed using standardized questionnaires (e.g., BDI for depression, SAS for anxiety).Functional Assessment: Joint function and pain are evaluated using clinical and patient-reported outcome measures.
|
|
intra-articular combined extra-articular hip pain group
|
Assessment of Pain Sources: Patients are grouped based on intra-articular, extra-articular, or combined intra- and extra-articular hip pain.Psychological Assessment: Depression and anxiety are assessed using standardized questionnaires (e.g., BDI for depression, SAS for anxiety).Functional Assessment: Joint function and pain are evaluated using clinical and patient-reported outcome measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the Beck Depression Inventory (BDI)
Time Frame: 5 minutes
|
The BDI is a self-assessment scale that has been demonstrated to be a reliable and valid tool for evaluating depressive symptoms.
The BDI comprises 21 items, each item is assigned a score on a scale of 0 to 3, with higher scores indicating a greater severity of depressive symptoms.
|
5 minutes
|
|
the Zung Self-Rating Anxiety Scale (SAS)
Time Frame: 5 minutes
|
The SAS is a self-assessment instrument designed to evaluate the presence and severity of anxiety symptoms.
The SAS consists of 20 items, each item consisting of four statements, and each item is scored on a scale of 1 to 4. A higher score indicates a higher level of anxiety.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the Visual Analogue Scale (VAS)
Time Frame: 2 minutes
|
for the assessment of the level of hip pain perceived by the patient
|
2 minutes
|
|
the Pain Sensitivity Questionnaire (PSQ)
Time Frame: 5 minutes
|
for the assessment of the individual's sensitivity to pain
|
5 minutes
|
|
The Hip Outcome Score Activities of Daily Living (HOS-ADL)
Time Frame: 5 minutes
|
evaluate the functional activities necessitated by daily life with the hip
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5 minutes
|
|
The Hip Outcome Score - Sport-specific subscale (HOS-SSS)
Time Frame: 5 minutes
|
assess the capacity to perform sports activities
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5 minutes
|
|
the modified Harris Hip Score (mHHS)
Time Frame: 5 minutes
|
assess the functional level of the hip joint
|
5 minutes
|
|
the international hip outcome tool (IHOT-12)
Time Frame: 5 minutes
|
assess the functional level of the hip joint
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chunbao Li, The Fourth Medical Centre of the General Hospital of the People's Liberation Army
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2023
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
September 22, 2024
First Submitted That Met QC Criteria
September 22, 2024
First Posted (Actual)
September 25, 2024
Study Record Updates
Last Update Posted (Actual)
September 26, 2024
Last Update Submitted That Met QC Criteria
September 24, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023KY031-KS001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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