Randomized Controlled TrialTreatment: Exercise & MovementClinical RelevanceDOI
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Study Summary

Background

Myofascial pain syndrome is a common and significant musculoskeletal disorder that causes chronic pain in multiple body sites, particularly among older adults. With advancing age, the prevalence of musculoskeletal pain increases to 40%–60%, becoming a major cause of disability, work incapacity, and financial burden. Myofascial trigger points (MTrPs) are hypersensitive spots within taut bands of skeletal muscle that produce localized or referred pain, and they represent the primary source of myofascial pain syndrome. These trigger points may develop from acute traumatic injury or repetitive microtrauma, and additional trigger points can form as stress increases on problematic muscle fibers.

Because chronic MTrPs reduce daily function and quality of life, early therapeutic intervention is important to reduce sensitization. Self-exercise for myofascial release is frequently recommended as a treatment approach, typically performed with compression tools such as foam rollers or tight balls that are simple to use, inexpensive, and easily available. A therapeutic inflatable ball offers particular advantages because its firmness can be adjusted by controlling air pressure according to individual need, and it can concentrate pressure at specific areas such as MTrPs. However, clinical evidence has been insufficient regarding the effectiveness of self-exercise with a therapeutic inflatable ball (SEIB) for desensitizing trigger points in elderly patients with myofascial pain syndrome.

What They Did

This study was designed as a single-blind, randomized, controlled noninferiority trial conducted on a university campus. The researchers recruited elderly individuals who had MTrPs in the upper trapezius on at least one side for 3 months or longer. Diagnosis of MTrPs followed established criteria including palpable hypersensitive tender spots in taut bands, pain reproduced by compression, local twitch response on muscle palpation, and referred or spontaneous pain elicited by firm compression. Participants were excluded if they had a history of neck and shoulder surgery, neurological deficits in the upper extremities, other ongoing treatment, or medication use for 1 month or longer.

Ultimately, 40 elderly patients completed the study and were randomly allocated to either the SEIB group (n=22) or the ultrasound (US) therapy group (n=18).

Both groups received eight treatment sessions over 4 consecutive weeks. The US group received 5 minutes of continuous ultrasound therapy per session at 1 MHz frequency and 1.0 W/cm² intensity. The SEIB group used a durable silicone therapeutic inflatable ball measuring 6.5 cm in diameter, with pressure adjusted individually using an air pump. Participants performed three stages of SEIB for a total of 10 minutes: gentle rubbing of the sternocleidomastoid muscle, pressure on the pectoralis major to restore muscle balance, and direct pressure on marked MTrPs in the upper trapezius.

Outcome measures included visual analog scale (VAS) for pain intensity, pressure pain threshold (PPT), and cervical lateral flexion (CLF), assessed at baseline and at 1, 2, 3, and 4 weeks. Two experienced evaluators who were blinded to group allocation conducted all measurements.

What They Found

The noninferiority test indicated that SEIB was not inferior to US therapy for all three primary outcomes. For the VAS, PPT, and CLF, the upper bound of the 95% confidence interval of the mean difference between groups did not exceed the predetermined noninferiority margins of 1.5 cm, 1 kg, and 11 degrees respectively. This finding was consistent in both per-protocol and intention-to-treat analyses.

Between-group comparisons showed no significant differences in VAS (F=2.579; p=0.117), PPT (F=0.245; p=0.624), or CLF (F=2.072; p=0.159). Within-group comparisons revealed that both groups showed significant improvements over time. For VAS, both groups showed significant decreases at 1, 2, 3, and 4 weeks compared with baseline. For PPT, the SEIB group showed significant increases at 3 and 4 weeks, while the US group showed significant increase at 4 weeks.

For CLF, both groups showed significant increases at 4 weeks. Effect sizes showed large decreases in VAS for both groups at 4 weeks, large increases in CLF for both groups, a large increase in PPT for the SEIB group, and a moderate increase in PPT for the US group. Specifically, the SEIB group showed a 46% decrease in VAS, a 30% increase in PPT, and a 32% increase in CLF at 4 weeks.

The recovery process followed a characteristic pattern: pain reduction occurred first at 1 week, followed by pressure threshold improvement at 3 weeks, and finally joint flexibility gains at 4 weeks. No side effects or uncomfortable events occurred in either group during the intervention period.

What This Means

This study provides important clinical evidence that self-exercise with a therapeutic inflatable ball is as effective as ultrasound therapy for treating myofascial pain syndrome in elderly patients. The noninferiority finding means that patients can achieve comparable benefits from a self-administered, low-cost intervention that does not require clinic visits or specialized equipment beyond an inflatable ball. This has significant practical implications for elderly patients who may have limited access to physical therapy clinics, transportation challenges, or financial constraints.

For clinicians, these results support recommending SEIB as a practical home-based treatment option for elderly patients with upper trapezius trigger points. The staged approach used in this study—addressing the sternocleidomastoid, pectoralis major, and finally the trigger points themselves—provides a structured protocol that can be taught to patients. The finding that pain reduces before pressure threshold and flexibility improve helps set appropriate expectations for patients beginning self-treatment.

The high accessibility and low cost of SEIB make it particularly valuable for elderly populations, who often face multiple barriers to ongoing clinical care. However, the lack of long-term follow-up means that the durability of these effects remains uncertain, and the small sample size with predominantly female participants limits generalizability. Future research should investigate whether home-based SEIB can maintain therapeutic effects over longer periods and should include more diverse populations.

45/100
Evidence StrengthModerate
Study Quality
Sample Size
Replication
46%
VAS Pain Reduction in SEIB Group at 4 Weeks
30%
PPT Increase in SEIB Group at 4 Weeks
32%
CLF Increase in SEIB Group at 4 Weeks
p=0.117
Between-Group VAS Comparison
Enrolled

40

Randomized
n=22

SEIB

Self-exercise with therapeutic inflatable ball, 10 min/session, 2x/week for 4 weeks

n=18

US Therapy

Ultrasound therapy 1MHz, 1.0 W/cm², 5 min/session, 2x/week for 4 weeks

Results Comparison

VAS Pain Score (0-10 cm)

cm at 4 weeks
SEIB3.34 cm at 4 weeks
US2.67 cm at 4 weeks

PPT (kg/cm²)

kg/cm² at 4 weeks
SEIB2.5 kg/cm² at 4 weeks
US2.45 kg/cm² at 4 weeks

CLF (degrees)

degrees at 4 weeks
SEIB28.18 degrees at 4 weeks
US26.73 degrees at 4 weeks

Key Findings

SEIB was noninferior to ultrasound therapy for all outcomesHigh

The 95% CI upper bounds for mean differences in VAS, PPT, and CLF did not exceed noninferiority margins of 1.5 cm, 1 kg, and 11° respectively in per-protocol analysis

No significant between-group differences in any outcome measureHigh

VAS (F=2.579; p=0.117), PPT (F=0.245; p=0.624), and CLF (F=2.072; p=0.159) showed no significant group differences

Both groups showed significant within-group improvements over timeHigh

VAS decreased significantly from week 1; PPT increased at 3 weeks (SEIB) and 4 weeks (US); CLF increased at 4 weeks in both groups

Characteristic recovery sequence identifiedMedium

Pain reduction occurred first (1 week), followed by pressure threshold improvement (3 weeks), then flexibility gains (4 weeks)

Large effect sizes for pain reduction in both groupsMedium

ES for VAS was -1.57 in both groups at 4 weeks; PPT ES was 1.56 (SEIB) and 0.48 (US)

Study Methodology
Study Design
Single-blind, randomized, controlled noninferiority trial
Sample Size
40
Duration
4 weeks with measurements at baseline, 1, 2, 3, and 4 weeks
Population
Elderly adults (mean age ~69 years) with myofascial trigger points in upper trapezius for ≥3 months
Outcome Measures
Visual Analog Scale (VAS) · Pressure Pain Threshold (PPT) · Cervical Lateral Flexion (CLF) · Mini-Mental State Examination-Korean version (MMSE-K) · Short Form 36 Health Survey (SF-36)

Strengths

  • Randomized controlled noninferiority design with appropriate statistical methodology
  • Blinded outcome assessors to reduce measurement bias
  • Multiple outcome measures capturing different dimensions of myofascial pain (pain intensity, pressure sensitivity, functional mobility)
  • Detailed, reproducible SEIB protocol with staged progression

Limitations

  • Small sample size (40 completers) limits statistical power and generalizability
  • Predominantly female participants (40/40 completers were women) restricts applicability to elderly men
  • No long-term follow-up to assess durability of treatment effects
  • No true placebo or no-treatment control group due to ethical concerns
  • Single-center study on a university campus may limit external validity

Key Takeaways for Patients

What This Means for You

  1. 01You can achieve similar pain relief doing self-exercises at home with an inflatable ball as you would receiving ultrasound therapy at a clinic
  2. 02Pain relief often comes first (within 1 week), while increased flexibility takes the full 4 weeks to develop
  3. 03The inflatable ball allows you to adjust pressure to your comfort level, starting gentle and increasing as you tolerate it
  4. 04This self-treatment approach is safe, inexpensive, and convenient for older adults with neck and shoulder trigger points
  5. 05Talk to your physical therapist about learning the proper technique before starting home self-treatment

Read the Full Paper

Access the complete peer-reviewed study from The Journal of Alternative and Complementary Medicine

View Full Study

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