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Enrolling by invitationNCT06611722Updated Sep 26, 2024

The Differences in the Psychological States of Patients with Different Chronic Hip Pain

An observational study in Psychological Disorders and Hip Pain Chronic, sponsored by ChunBao Li. Enrolling by invitation at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by ChunBao Li · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
70
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psychological Disorders
  • Hip Pain Chronic

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Keywords

  • hip
  • pain
  • Psychological Disorders
  • depression
  • anxiety
03

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPsychological and Functional Assessment

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

  2. 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.

    Time frame: 5 minutes

Secondary outcomes

  1. the Visual Analogue Scale (VAS)

    for the assessment of the level of hip pain perceived by the patient

    Time frame: 2 minutes

  2. the Pain Sensitivity Questionnaire (PSQ)

    for the assessment of the individual's sensitivity to pain

    Time frame: 5 minutes

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

    evaluate the functional activities necessitated by daily life with the hip

    Time frame: 5 minutes

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

    assess the capacity to perform sports activities

    Time frame: 5 minutes

  5. the modified Harris Hip Score (mHHS)

    assess the functional level of the hip joint

    Time frame: 5 minutes

  6. the international hip outcome tool (IHOT-12)

    assess the functional level of the hip joint

    Time frame: 5 minutes

06

Study locations

1 site
  • General Hospital of the Chinese People's Liberation Army
    Beijing, Beijing 100000, China
07

Registry details

Key details

Study ID
NCT06611722
Lead sponsor
ChunBao Li
Responsible party
ChunBao Li (deputy chief physician, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Sep 25, 2024
Start date
Dec 5, 2023
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Sep 26, 2024

Study contacts

Chunbao Li
study director · The Fourth Medical Centre of the General Hospital of the People's Liberation Army

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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