NCT05917262

Brief Summary

Although shoulder surgeries can effectively relieve pain intensity and restore shoulder function, some patients reported persistent post-operative pain at the 6-month post-surgery follow-up visit. This randomized study aims to determine the effectiveness of three different types of bio-psychosocial support to pre-operative shoulder surgery patients. This study will examine the differential effects of brief mindfulness-based breathing, heart rate variability biofeedback (HRV-BF), and cognitive behavioral pain psychoeducation for pre-operative patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress91%
Nov 2023Jul 2026

First Submitted

Initial submission to the registry

May 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 13, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

May 17, 2023

Last Update Submit

November 20, 2023

Conditions

Pain, PostoperativeShoulder Pain

Keywords

Shoulder painPostoperative painmindfulnessHRVbiofeedback

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale change

    Subjective post-surgical pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

  • Shoulder function change_1

    American Shoulder and Elbow Surgeons Shoulder Score (ASES). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

    Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

  • Shoulder function change_2

    Constant Score to measure the objective ROM. Scores range from 0 to 100 points, representing worst and best shoulder function, respectively.

    Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

  • Subjective sleep quality change

    Pittsburgh sleep quality index (PSQI). The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

    Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

  • Emotion-related measurements change

    Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression.

    Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

  • HRQoL change

    EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL

    Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Secondary Outcomes (11)

  • Pain-related fear

    Baseline as predictive factor.

  • Pain catastrophizing

    Baseline as predictive factor.

  • Neuropsychological change - general cognitive ability

    Baseline, and at the 24th week post-operative outpatient follow-up appointments.

  • Neuropsychological change - subjective cognitive ability

    Baseline, and at the 24th week post-operative outpatient follow-up appointments.

  • Neuropsychological change - processing speed

    Baseline, and at the 24th week post-operative outpatient follow-up appointments.

  • +6 more secondary outcomes

Other Outcomes (1)

  • Cytokine

    During surgery

Study Arms (3)

Mindfulness-based breathing

EXPERIMENTAL

20-minute mindfulness-based breathing training

Behavioral: Mindfulness-based breathing

HRV biofeedback

EXPERIMENTAL

20-minute HRV biofeedback

Behavioral: HRV biofeedback

cognitive-behavioral pain psychoeducation

ACTIVE COMPARATOR

20-minute psychoeducation session

Behavioral: cognitive-behavioral pain psychoeducation

Interventions

Mindfulness-based breathingBEHAVIORAL

The 20-minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experiences in a non-judgmental fashion.

Mindfulness-based breathing
HRV biofeedbackBEHAVIORAL

The 20-minute HRV biofeedback is based on the resonant frequency breathing with an external pacemaker. Generally, the breath rhythm is between 4.5 and 6.5 times per min.

HRV biofeedback
cognitive-behavioral pain psychoeducationBEHAVIORAL

The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.

cognitive-behavioral pain psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • shoulder pain patients with
  • (1) pain ≥3months and ≥3 days per week
  • (2) pain intensity ≥ 40 (VAS scale from 0 no pain to 100 very painful)
  • (3) the surgical indication would be based on orthopedics opinions

You may not qualify if:

  • history of shoulder surgery in the prior 3 years
  • osteoporotic vertebral fractures or rheumatologic diseases
  • chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
  • neurological disease (i.e., stroke, parkinson's disease, etc..)
  • psychiatric disease (i.e., dementia, depression, schizophrenia, etc)
  • cancer
  • patients who practiced yoga, meditation, chi-qong, mindfulness, or deep breathing exercises more than three times per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeShoulder Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Chih-Hao Chiu, M.D.

    Chang Gung MH

    STUDY CHAIR

Central Study Contacts

Poyu Chen, PhD

CONTACT

+886-3211-8800poyuchen@gap.cgu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 23, 2023

Study Start

November 13, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

TW(1)