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The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain

Primary Purpose

Chronic Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Isometric exercise for shoulder external rotators
Sponsored by
Jorge Fuentes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Shoulder Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female having a chronic shoulder soft-tissue injury of at least 3 month duration resulting in a mild to moderate level of disability (Constant score scale), pain intensity score between 3 and 8 points (pain intensity numerical rating scale), and age between 18 and 65 years.

Exclusion Criteria:

  • Participants were excluded if they had any contraindications related to the application of isometric exercise, neurological problems (central or peripheral), concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic disease conditions, had participated in any moderate or vigorous physical activity in the las 72 hours previous the outcome assessment.

Sites / Locations

  • Hospital Traumatológico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 20% maximal voluntary isometric contraction

Group 2 80% maximal voluntary isometric contraction

Arm Description

Patients in group 1 received a five-series Isometric Contraction of shoulder external rotators at 20% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.

Patients in group 2 received a five-series Isometric Contraction of shoulder external rotators at 80% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.

Outcomes

Primary Outcome Measures

Pain intensity Numerical Rating Scale
The Pain intensity Numerical Rating Scale is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a number on a horizontally depicted 11-point scale from 0 (no pain) to 10 (worst possible pain). Based on its several advantages (i.e. more responsive, sensitive and easy to administer) over other pain measuring scales, the PI-NRS has been recommended as a core outcome measure in clinical trials of chronic pain treatments. The minimal clinically important change for this scale has been reported to range from 1.5 to 3.2 points. Other authors have determined a meaningful clinical change of 2 points from baseline pain scores.

Secondary Outcome Measures

Shoulder function
The shoulder function was assessed by the Constant Score scale. This is a multi-item functional scale assessing pain, activities of daily living, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function respectively. Pain and activities of daily living (subjective aspects receiving 35 points) are answered by the patient ; and range of motion and strength (objective aspects receiving 65 points) require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
Muscle pain sensitivity
Muscle pain sensitivity was evaluated through the pressure pain threshold, or the minimum pressure that induces pain or discomfort. Pressure pain thresholds measurements have been shown to have good or excellent inter-rater intraclass correlation coeficient values ranging from 0.74 to 0.90, and intra-rater reliability interclass correlation coefficient values ranging from 0.75 to 0.99. The minimal clinically important change calculated for this outcome has been reported to be ≥ 1.10 Kg/cm2/s

Full Information

First Posted
July 13, 2020
Last Updated
July 15, 2020
Sponsor
Jorge Fuentes
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1. Study Identification

Unique Protocol Identification Number
NCT04475965
Brief Title
The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain
Official Title
The Influence of the Intensity of Isometric Exercise on Pain Intensity, Muscle Pain Sensitivity and Function in Patients With Chronic Shoulder Pain: A Parallel Single-blind Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
October 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jorge Fuentes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the influence of the intensity of Isometric Contraction of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary isometric contraction) on pain intensity, pain thresholds, and function in chronic pain shoulder patients.
Detailed Description
This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41) received a five-series Isometric Contraction of shoulder external rotators at 20% maximal voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period. Outcome measures included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain intensity numerical rating score), and shoulder function (Constant Score).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to groups by using a random number table. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.
Masking
Outcomes Assessor
Masking Description
The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 20% maximal voluntary isometric contraction
Arm Type
Experimental
Arm Description
Patients in group 1 received a five-series Isometric Contraction of shoulder external rotators at 20% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.
Arm Title
Group 2 80% maximal voluntary isometric contraction
Arm Type
Active Comparator
Arm Description
Patients in group 2 received a five-series Isometric Contraction of shoulder external rotators at 80% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.
Intervention Type
Other
Intervention Name(s)
Isometric exercise for shoulder external rotators
Intervention Description
The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).
Primary Outcome Measure Information:
Title
Pain intensity Numerical Rating Scale
Description
The Pain intensity Numerical Rating Scale is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a number on a horizontally depicted 11-point scale from 0 (no pain) to 10 (worst possible pain). Based on its several advantages (i.e. more responsive, sensitive and easy to administer) over other pain measuring scales, the PI-NRS has been recommended as a core outcome measure in clinical trials of chronic pain treatments. The minimal clinically important change for this scale has been reported to range from 1.5 to 3.2 points. Other authors have determined a meaningful clinical change of 2 points from baseline pain scores.
Time Frame
Baseline through the end of the intervention (2 week period)
Secondary Outcome Measure Information:
Title
Shoulder function
Description
The shoulder function was assessed by the Constant Score scale. This is a multi-item functional scale assessing pain, activities of daily living, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function respectively. Pain and activities of daily living (subjective aspects receiving 35 points) are answered by the patient ; and range of motion and strength (objective aspects receiving 65 points) require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
Time Frame
Baseline through the end of the intervention (2 week period)
Title
Muscle pain sensitivity
Description
Muscle pain sensitivity was evaluated through the pressure pain threshold, or the minimum pressure that induces pain or discomfort. Pressure pain thresholds measurements have been shown to have good or excellent inter-rater intraclass correlation coeficient values ranging from 0.74 to 0.90, and intra-rater reliability interclass correlation coefficient values ranging from 0.75 to 0.99. The minimal clinically important change calculated for this outcome has been reported to be ≥ 1.10 Kg/cm2/s
Time Frame
Baseline through the end of the intervention (2 week period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female having a chronic shoulder soft-tissue injury of at least 3 month duration resulting in a mild to moderate level of disability (Constant score scale), pain intensity score between 3 and 8 points (pain intensity numerical rating scale), and age between 18 and 65 years. Exclusion Criteria: Participants were excluded if they had any contraindications related to the application of isometric exercise, neurological problems (central or peripheral), concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic disease conditions, had participated in any moderate or vigorous physical activity in the las 72 hours previous the outcome assessment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Neira, BSc
Organizational Affiliation
Concepcion University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Traumatológico
City
Concepción
State/Province
Bio Bio
ZIP/Postal Code
4030000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain

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