Massage for Neck Pain

Overseen By Joel Bialosky, PT, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Blood thinners

Disqualifiers: Diabetes, Neck surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

53 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using blood thinning medication.

What data supports the effectiveness of the treatment for neck pain?

Research shows that therapeutic massage can be more beneficial than self-care for chronic neck pain, and it helps improve the range of motion and muscle relaxation. Additionally, massage has been shown to be effective in reducing neck pain and improving quality of life in various studies. ^{1 2 3 4 5}

Is massage therapy generally safe for neck pain?

Massage therapy is generally considered safe, but there are some risks, especially with spinal manipulation, which can lead to serious issues like disc herniation and spinal cord injury. However, these adverse events are rare. ^{2 6 7 8 9}

How does massage treatment for neck pain differ from other treatments?

Massage for neck pain is unique because it involves hands-on manipulation of muscles to relieve pain and improve relaxation, unlike other treatments that may rely on medication or physical devices. It is a popular complementary therapy, but its effectiveness can vary based on the frequency and duration of sessions, which are still being studied to determine the optimal 'dose' for best results. ^{1 2 10 11 12}

What is the purpose of this trial?

This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.

Eligibility Criteria

This trial is for individuals aged 18 to 60 who have been experiencing neck pain for at least three months, with a pain intensity of at least 4 out of 10 in the last day. It's not suitable for those with arm pain or other conditions that might affect their response to massage.

Inclusion Criteria

I have had neck pain for 3 months or more.

I am currently experiencing neck pain, with or without arm pain.

My neck pain has been 4 out of 10 or worse in the last day.

Exclusion Criteria

I have had a whiplash injury in the past.

Pregnancy

I have a blood clotting disorder like hemophilia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to receive a pain inducing massage, pain free massage, or place their hand in a cold water bath

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief and sensitivity immediately following the intervention

Immediate

Treatment Details

Interventions

• Massage

Trial Overview The study aims to see if how much pressure causes someone pain can predict relief from a painful massage and compares this relief to that from a non-painful massage or placing one's hand in cold water. Participants are randomly assigned to one of these three interventions.

Participant Groups

Group I: Pain Inducing Massage Experimental Treatment 1 Intervention

Participants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 5/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable.

Group II: Cold Water Bath Active Control 1 Intervention

Participants will place their non-dominant hand into water cooled by a refrigeration unit (NESLAB RTE 7 Digital One, Thermo Scientific Co., Massachusetts, USA) that circulates water continuously to maintain a constant temperature of 6 degrees Celsius (males) or 8 degrees Celsius (females). The participant will place his or her hand in the cooled water for 60 seconds followed by a 30 second break in which the participant will remove his or her hand from the water. This will occur 4 times for a total immersion time of 240 seconds.

Group III: Pain Free Massage Active Control 1 Intervention

Participants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 0/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable.

Massage is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Massage Therapy for:

• Chronic neck pain
• Muscle soreness
• Stress relief

Approved in European Union as Massage Therapy for:

• Neck pain
• Back pain
• Musculoskeletal disorders

Approved in Canada as Massage Therapy for:

• Chronic pain management
• Muscle relaxation
• Wellness

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

In a study of 64 patients with chronic neck pain, those receiving therapeutic massage showed significantly greater improvements in neck function and symptom bothersomeness compared to those using a self-care book, particularly at the 10-week mark.

The results indicate that therapeutic massage is a safe treatment option for chronic neck pain, with benefits observed in the short term, although these effects may diminish over time, suggesting the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of therapeutic massage for chronic neck pain. Sherman, KJ., Cherkin, DC., Hawkes, RJ., et al.[2022]

In a study involving 45 women with chronic neck pain, connective tissue massage (CTM) showed significant improvements in muscle relaxation response as measured by electromyography biofeedback (EMG-BF), indicating its effectiveness for muscle relaxation.

Classic massage (CM) was effective in increasing the pressure pain threshold in the sternocleidomastoid muscle, suggesting it can help reduce pain in individuals with chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. Bakar, Y., Sertel, M., Oztürk, A., et al.[2014]

Therapeutic massage significantly improves the range of motion in patients with neck pain, particularly in flexion and lateral bending, as shown in a study of 60 patients aged 37-82 years.

While both therapeutic massage and standard rehabilitation (kinesiotherapy and physiotherapy) led to pain reduction and improved function, the addition of massage provided specific benefits in flexibility, indicating it can be an effective complementary treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of therapeutic massage in patients with neck pain. Topolska, M., Chrzan, S., Sapuła, R., et al.[2012]

In a study of 38 women with neck pain, those receiving the integrative muscular movement technique (IMMT) showed significantly greater improvements in cervical range of motion across all measured movements compared to those receiving Swedish massage.

IMMT also resulted in a greater reduction in pain levels, with an average decrease of 1.75 units on a pain scale compared to only 0.3 units for Swedish massage, suggesting that IMMT may be a more effective treatment for chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental integrative muscular movement technique enhances cervical range of motion in patients with chronic neck pain: a pilot study. Rohe, BG., Carter, R., Thompson, WR., et al.[2015]

The TOMCATT study aimed to compare caregiver-applied massage and therapist-delivered massage for Veterans with chronic neck pain, but faced significant retention challenges, leading to a modification of the trial design to focus on therapist-delivered massage only.

Despite initial difficulties, the modified study successfully exceeded recruitment goals and is expected to provide valuable insights into the efficacy of therapist-delivered massage for chronic neck pain by early 2023.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial. Munk, N., Daggy, JK., Evans, E., et al.[2022]

In a study of 21 female patients with chronic tension headaches, 10 sessions of upper body massage significantly improved cervical movement and reduced pain levels, as measured by the Visual Analogue Scale (VAS) and Finnish Pain Questionnaire (FPQ).

The massage treatment also led to improvements in muscle activity in the frontalis muscle, and patients reported decreased neck pain and improved mood, as indicated by the Beck Depression Inventory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of massage in patients with chronic tension headache. Puustjärvi, K., Airaksinen, O., Pöntinen, PJ.[2019]

A systematic review of 60 studies on massage therapy in children found that while many studies did not report adverse events (AEs), 26.6% reported at least one AE, ranging from mild to severe.

Notably, there was a concerning association between abdominal massage and severe AEs, including volvulus in premature infants, which raises safety concerns and suggests caution in using abdominal massage for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with paediatric massage therapy: a systematic review. Karkhaneh, M., Zorzela, L., Jou, H., et al.[2022]

A review of 40 reports from 2003 to 2013 identified 138 adverse events (AEs) related to pain-related massage, highlighting that while serious complications like disc herniation and spinal cord injury can occur, the overall incidence of these events is low.

The findings suggest that although massage therapies carry some risks, particularly with spinal manipulation, they are generally considered safe when performed by qualified practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. Yin, P., Gao, N., Wu, J., et al.[2022]

A 47-year-old man suffered a cervical cord injury and myelopathy after receiving a neck massage, highlighting the potential risks associated with this practice.

Despite undergoing surgery and 6 months of rehabilitation, the patient experienced lasting hand dysfunction and minor walking issues, emphasizing the need for caution when performing neck massages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cord injury after massage. Lee, TH., Chiu, JW., Chan, RC.[2016]

A 47-year-old woman developed acute cervical radiculopathy after a brief deep tissue massage of the anterior scalene muscle, highlighting a rare but serious risk associated with this therapy.

The patient successfully recovered strength and improved electrodiagnostic findings after receiving targeted nerve blocks and participating in a rehabilitation program, emphasizing the importance of careful technique in massage therapy, especially for underweight individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute cervical radiculopathy after anterior scalene muscle massage: A case report. Chung, SJ., Soh, Y.[2023]

Myofascial release therapy and connective tissue massage showed short-term improvements in pain intensity and pain threshold for neck pain compared to no treatment or exercise alone, but the overall evidence is limited due to the small number of studies (8 total) reviewed.

Western massage therapies were not found to be superior to other active therapies for neck pain, indicating that while they may provide some relief, they should not be considered the best option compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Western Massage Therapies in the Management of Neck Pain: A Systematic Review. Mete, O., Kaya, DO., Keskin, M., et al.[2023]

This study will evaluate the effectiveness of different massage treatment schedules for chronic neck pain in 228 participants, aiming to identify the optimal number of sessions and duration for maximum benefit.

By comparing outcomes over a 26-week period, the research will clarify whether longer treatment (10 weeks) is more effective than the initial 4-week regimen, addressing previous gaps in massage therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial. Sherman, KJ., Cook, AJ., Kahn, JR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of therapeutic massage for chronic neck pain. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. [2014]

3. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of therapeutic massage in patients with neck pain. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Experimental integrative muscular movement technique enhances cervical range of motion in patients with chronic neck pain: a pilot study. [2015]

5. Canada pubmed.ncbi.nlm.nih.gov

Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of massage in patients with chronic tension headache. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with paediatric massage therapy: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cervical cord injury after massage. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Acute cervical radiculopathy after anterior scalene muscle massage: A case report. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Western Massage Therapies in the Management of Neck Pain: A Systematic Review. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial. [2021]