Psychological DisordersNCT06611722
The Differences in the Psychological States of Patients with Different Chronic Hip Pain
An observational study of Psychological Disorders and Hip Pain Chronic, run by ChunBao Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Psychological Disorders, Hip Pain Chronic
- What is being tested?
- Psychological and Functional Assessment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 1 Oct 2024
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- The subject must be at least 16 years old and of sound mind；
- Chronic hip pain persisting for a duration exceeding 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, 100000
About this study
Official title: 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.
- Conditions
- Psychological Disorders, Hip Pain Chronic
- Being tested
- Psychological and Functional Assessment
- Keywords
- hip, pain, Psychological Disorders, depression, anxiety
- Medical subject headings
- Mental Disorders, Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological and Functional AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intra-articular hip pain group | Not described Receives: Other: Psychological and Functional Assessment | |
| extra-articular hip pain group | Not described Receives: Other: Psychological and Functional Assessment | |
| intra-articular combined extra-articular hip pain group | Not described Receives: Other: Psychological and Functional Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Beck Depression Inventory (BDI)
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.
Measured: 5 minutes
the Zung Self-Rating Anxiety Scale (SAS)
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.
Measured: 5 minutes
Secondary outcomes (6)
the Visual Analogue Scale (VAS)
for the assessment of the level of hip pain perceived by the patient
Measured: 2 minutes
the Pain Sensitivity Questionnaire (PSQ)
for the assessment of the individual's sensitivity to pain
Measured: 5 minutes
The Hip Outcome Score Activities of Daily Living (HOS-ADL)
evaluate the functional activities necessitated by daily life with the hip
Measured: 5 minutes
The Hip Outcome Score - Sport-specific subscale (HOS-SSS)
assess the capacity to perform sports activities
Measured: 5 minutes
the modified Harris Hip Score (mHHS)
assess the functional level of the hip joint
Measured: 5 minutes
the international hip outcome tool (IHOT-12)
assess the functional level of the hip joint
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start5 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DisordersStudies 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
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChunBao Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ChunBao Li, Chinese PLA General Hospital
- Investigators
- Chunbao Li, Study director, The Fourth Medical Centre of the General Hospital of the People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611722
- Sponsor's protocol ID
- 2023KY031-KS001
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Retrospective Cross-sectional Study of the Differences in the Psychological States of Patients with Different Chronic Hip Pain
- ClinicalTrials.gov ID
- NCT06611722
- Acronym / sponsor ID
- 2023KY031-KS001
- Conditions
- Psychological Disorders, Hip Pain Chronic
- Keywords
- hip, pain, Psychological Disorders, depression, anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ChunBao LiUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 25 Sep 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intra-articular hip pain group | – | Other: Psychological and Functional Assessment |
| extra-articular hip pain group | – | Other: Psychological and Functional Assessment |
| intra-articular combined extra-articular hip pain group | – | Other: Psychological and Functional Assessment |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- The subject must be at least 16 years old and of sound mind；
- Chronic hip pain persisting for a duration exceeding 3 months.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Psychological and Functional AssessmentAssessment 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. | Other | extra-articular hip pain group, intra-articular combined extra-articular hip pain group, intra-articular hip pain group |
Primary outcome
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.
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.
6 secondary outcomes
the Visual Analogue Scale (VAS)
Time frame: 2 minutes
the Pain Sensitivity Questionnaire (PSQ)
Time frame: 5 minutes
The Hip Outcome Score Activities of Daily Living (HOS-ADL)
Time frame: 5 minutes
The Hip Outcome Score - Sport-specific subscale (HOS-SSS)
Time frame: 5 minutes
the modified Harris Hip Score (mHHS)
Time frame: 5 minutes
the international hip outcome tool (IHOT-12)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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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.
Chunbao Li study director
The Fourth Medical Centre of the General Hospital of the People's Liberation Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Disorders and Hip Pain Chronic, run by ChunBao Li at 1 site in China.
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 2 inclusion and 4 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Beck Depression Inventory (BDI) (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.