Acupressure in Reducing Post-TBI Fatigue

NCT04429126 | Completed

• 1 other identifier: 109059-E
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior works have demonstrated that it may profoundly impact the ability to return to productive activity and cognitive functions. However, few interventions have been applied in this population.The purpose of the current will be to test the effect of acupressure on fatigue reduction after traumatic brain injury.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Self-reported feeling of tiredness, is measured by the Chinese version of The Mental fatigue Scale (MFS, higher scores indicate greater mental fatigue) and Multidimensional Fatigue Inventory (MFI, higher score indicates more fatigue)

  4 weeks

Secondary Outcomes (5)

• Memory function

  4 weeks

• Attention function

  4 weeks

• Heart rate variability

  My ECG E3-8010

• Brain waves

  4 weeks

• Sleep quality

  4 weeks

Study Arms (3)

4-point acupressure group

EXPERIMENTAL

The 5-point acupressure group will be instructed on the following acupressure points: sanyinjiao (SP6), Zu San Li (ST36), shenmen (TF4), Yongquan (KI-1), and He Gu (LI4). Bilateral 1.5 min for each point, three times daily for 4 weeks.

Behavioral: Acupressure

4 -point acupressure group

ACTIVE COMPARATOR

The 2-point acupressure group will be instructed on the following acupressure points: He Gu (LI4) and Tai Chong (LV3). Bilateral 1.5 min for each point, three times daily for 4 weeks.

Behavioral: Acupressure

Usual care

NO INTERVENTION

The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.

Interventions

Acupressure BEHAVIORAL

Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.

4 -point acupressure group; 4-point acupressure group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with traumatic brain injury over 6 months with initial GCS (admitted GCS) from 3-12.
• Aged between 20-65 years
• Are able to communicate in Chinese and Mandarin
• Are able to complete the questionnaires
• Complain of tiredness and cannot be restored even after a rest.
• No physical disability and visual impairment

You may not qualify if:

• With skin lesion
• had diagnosis of neuropathy and paraesthesia prior to study.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Hsiao-Yean Chiu

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hsiao-Yean Chiu, PhD

  School of Nursing, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: July 1, 2020
• Primary Completion: November 18, 2021
• Study Completion: December 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)