- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546838
Effects of Aerobic and Combined Exercise on Pain and Fatigue in Workers With Chronic Neck Pain (EIH-CNNP)
Acute Effects of Aerobic Versus Combined Aerobic and Cervical-Upper Extremity Resistance Exercise on Pressure Pain Threshold, Pain Perception, and Fatigue in Workers Exposed to High Ergonomic Risk With Chronic Non-specific Neck Pain: a Randomized Controlled Trial
This randomized controlled trial investigated the acute effects of aerobic exercise (AE) and combined aerobic and cervical-upper extremity resistance exercise (CE) on the pressure pain threshold (PPT), pain perception, and fatigue in workers with high ergonomic risk and chronic non-specific neck pain (CNNP).
A total of 78 workers were randomly assigned to AE, CE, or control groups. The AE and CE groups completed single 40-minute sessions, while the control group received a 30-minute educational session with additional seated rest periods before and after the session. PPT was assessed bilaterally at multiple anatomical sites using a digital pressure algometer. Neck pain, overall pain perception, and fatigue were evaluated using a numerical rating scale (NRS) before, immediately after, and 20 minutes after exercise.
The study focused on exercise-induced hypoalgesia (EIH) and was intended to inform brief, workplace-compatible exercise strategies to reduce pain, fatigue, and work-related musculoskeletal risks in this population.
Study Overview
Status
Intervention / Treatment
Detailed Description
This randomized controlled trial investigated the acute effects of aerobic exercise and combined aerobic and cervical-upper extremity resistance exercise on pain sensitivity, pain perception, and fatigue in workers with chronic non-specific neck pain exposed to high ergonomic risk.
Participants were recruited from occupational groups with high ergonomic risk and were assessed in two sessions. The first session was conducted in the workplace and included eligibility screening, demographic data collection, and ergonomic risk assessment. Participants were then randomly assigned to aerobic exercise, combined exercise, or control groups.
The second session was conducted in a university laboratory setting. Baseline assessments were performed, followed by the intervention. Outcome measures were collected before the intervention (T0), immediately after (T1), and 20 minutes after the intervention (T2).
The aerobic exercise group performed moderate-intensity cycling using a recumbent ergometer (64-76% of maximum heart rate), consisting of a 5-minute warm-up, 30 minutes of exercise, and a 5-minute cool-down. The combined exercise group performed aerobic exercise at the same intensity, followed by cervical and upper-extremity resistance exercises focusing on motor control and scapular stabilization. This protocol included a 5-minute warm-up, 15 minutes of aerobic exercise, 15 minutes of resistance exercise, and a 5-minute cool-down. The control group received a 30-minute educational session on exercise and workplace ergonomics.
Pain sensitivity was assessed using pressure pain threshold measurements obtained with a digital algometer at the C2, C5, and upper trapezius regions. Neck pain, overall body pain perception, and fatigue were evaluated using numerical rating scales (0-10).
Sample size was calculated using G*Power (v3.1.9.6) based on a previous study (effect size = 0.165 for a three-group design), with an alpha level of 0.05 and power of 0.80, resulting in a required sample of 78 participants. Considering a 20% drop-out rate, 95 participants were targeted.
Statistical analyses were performed using SPSS. Data normality was assessed using the Shapiro-Wilk test. Baseline differences between groups were analyzed using ANOVA and chi-squared tests. The primary analysis evaluated group × time interactions using repeated-measures ANOVA (T0, T1, T2), with Bonferroni post-hoc tests applied when appropriate. Statistical significance was set at p < 0.05.
The study focused on exercise-induced hypoalgesia (EIH) and aimed to compare the immediate and short-term responses to different exercise modalities in a working population with chronic neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Çankaya
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Ankara, Çankaya, Turkey (Türkiye), 06100
- Faculty of Physical Therapy adn Rehabilitation, Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 20-65 years
- Diagnosed with chronic non-specific neck pain within the past year
- Neck pain intensity ≥4 on a numerical rating scale for at least 3 months
- Actively employed for at least 1 year in similar occupational conditions
- High ergonomic risk (Rapid Upper Limb Assessment - RULA score ≥3)
Exclusion Criteria:
- Neurological, cardiopulmonary, or rheumatological disorders
- History of cervical surgery or traumatic injury
- Specific cervical or lumbar pathology
- Whiplash injury, or any traumatic musculoskeletal injury
- Recent physical therapy or regular exercise in the past six months
- Neck pain unresponsive to conservative treatment
- Diagnosed thoracic outlet syndrome, rotator cuff pathology, vertebrobasilar insufficiency, or frozen shoulder
- Pregnancy
- Use of antidepressant medication
- Positive clinical tests (Spurling, cervical distraction, Valsalva, radial, ulnar, and median nerve tension tests)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic Exercise
Participants performed moderate-intensity cycling using a recumbent ergometer in a single 40-minute session, including a 5-minute warm-up, 30 minutes of aerobic exercise, and a 5-minute cool-down.
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Moderate-intensity aerobic exercise performed using a recumbent cycle ergometer in a single 40-minute session.
The protocol included a 5-minute warm-up, 30 minutes of continuous cycling, and a 5-minute cool-down.
Exercise intensity was maintained at 64-76% of maximum heart rate and adjusted individually throughout the session.
No resistance or strength training exercises were included.
|
|
Experimental: Combined Exercise
Participants performed a combination of aerobic and resistance exercises in a single 40-minute session, including a 5-minute warm-up, 15 minutes of aerobic exercise, 15 minutes of resistance training targeting cervical and upper-extremity muscles, and a 5-minute cool-down.
|
Participants performed a combination of aerobic and resistance exercises in a single 40-minute session.
The protocol included a 5-minute warm-up, 15 minutes of moderate-intensity aerobic exercise (64-76% HRmax, Borg RPE 11-14), 15 minutes of resistance exercises targeting cervical and upper-extremity muscles, and a 5-minute cool-down.
The resistance program focused on cervical motor control and scapular stabilization, including chin tuck, cervical retraction with extension, scapular retraction, vertical pulling, horizontal shoulder abduction, scapular plane abduction, and shoulder elevation.
Each exercise was performed for 8-10 repetitions in two sets with 30-second rest intervals.
All exercises were supervised and performed with proper postural alignment.
|
|
Active Comparator: Informed Control
A 30-minute educational session on exercise benefits, workplace ergonomics, and postural recommendations.
Participants remained seated for 5 minutes before and after the session.
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Participants attended a 30-minute educational session on exercise benefits, workplace ergonomics, and postural recommendations.
Participants remained seated for 5 minutes before and after the session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold
Time Frame: Three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
|
Pressure pain threshold is assessed using a digital algometer to evaluate pain sensitivity. The value at which the sensation of pressure first becomes painful is recorded in lbf/cm². Three consecutive measurements are obtained at each site, and the mean value is used for analysis. Measurements are obtained bilaterally at the C2 region, C5 region, and upper trapezius muscle. |
Three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute Neck Pain Perception
Time Frame: Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
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Acute neck pain intensity is assessed using a numerical rating scale (0-10), a simple and widely used tool for evaluating pain.
Participants are asked to select the number that best represents their pain intensity.
Zero indicates no pain, and 10 represents the worst imaginable pain.
|
Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
|
|
Acute Overall Body Pain Perception
Time Frame: Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
|
Acute overall body pain perception is assessed using a numerical rating scale (0-10), a simple and widely used tool for evaluating pain.
Participants are asked to select the number that best represents their pain intensity.
Zero indicates no pain, and 10 represents the worst imaginable pain.
|
Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
|
|
Acute Fatigue
Time Frame: Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
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Acute fatigue is assessed using a numerical rating scale (0-10), a simple and widely used tool for evaluating fatigue.
Participants are asked to select the number that best represents their fatigue intensity.
Zero indicates no fatigue, and 10 represents the worst imaginable fatigue.
|
Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ergonomic Risk Level - Rapid Upper Limb Assessment (RULA)
Time Frame: Baseline
|
Ergonomic risk level is assessed using the RULA method to classify participants' workplace-related ergonomic risk at baseline.
|
Baseline
|
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Functional Aerobic Capacity 6-Minute Walk Test (6MWT)
Time Frame: Baseline
|
Functional aerobic capacity is assessed using the 6MWT.
The total walking distance is recorded to ensure that participants have sufficient functional capacity to safely complete the study procedure.
|
Baseline
|
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Physical Activity Level (IPAQ-SF)
Time Frame: Baseline
|
Physical activity level is assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF). The questionnaire evaluates the time spent in walking, moderate, and vigorous physical activities over the past 7 days. Time Frame: Baseline |
Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.
- Senarath ID, Chen KK, Weerasekara I, de Zoete RMJ. Exercise-induced hypoalgesic effects of different types of physical exercise in individuals with neck pain: A systematic review and meta-analysis. Pain Pract. 2023 Jan;23(1):110-122. doi: 10.1111/papr.13150. Epub 2022 Aug 2.
- Anarte-Lazo E, Bernal-Utrera C, Lopez-Amor M, Porras-Valencia E, Ruy-Diaz-Rojas FJ, Falla D, Rodriguez-Blanco C. Exercise-induced hypoalgesia after aerobic versus neck-specific exercise in people with acute/subacute whiplash-associated disorders: protocol for a randomised controlled trial. BMJ Open. 2022 Sep 22;12(9):e061679. doi: 10.1136/bmjopen-2022-061679.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA-CNNP-RCT-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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