NCT06611722

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 22, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

hippainPsychological Disordersdepressionanxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    5 minutes

Secondary Outcomes (6)

  • the Visual Analogue Scale (VAS)

    2 minutes

  • the Pain Sensitivity Questionnaire (PSQ)

    5 minutes

  • The Hip Outcome Score Activities of Daily Living (HOS-ADL)

    5 minutes

  • The Hip Outcome Score - Sport-specific subscale (HOS-SSS)

    5 minutes

  • the modified Harris Hip Score (mHHS)

    5 minutes

  • +1 more secondary outcomes

Study Arms (3)

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

Interventions

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 groupintra-articular combined extra-articular hip pain groupintra-articular hip pain group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • The subject must be at least 16 years old and of sound mind;
  • Chronic hip pain persisting for a duration exceeding 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Mental DisordersPainDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Chunbao Li

    The Fourth Medical Centre of the General Hospital of the People's Liberation Army

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
deputy chief physician

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 25, 2024

Study Start

December 5, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations