Targeted Physiotherapeutic Treatment for Aromatase Inhibitor-associated Musculoskeletal Pain in Breast Cancer Survivors

Summary

The primary objective of this trial is to assess the efficacy of targeted individualised physiotherapeutic treatment on aromatase inhibitor-associated musculoskeletal pain.

This trial asks a critical, previously unaddressed, question of clinical importance about management of musculoskeletal (MSK) pain secondary to aromatase inhibitor (AI) treatment of hormone receptor-positive breast cancer. Many breast cancer survivors taking AIs experience muscle and/or joint pain, which may cause many to stop taking AIs and may inhibit exercise or physical activity, despite its known health benefits.

Physiotherapeutic treatment is considered a standard management strategy for many MSK pain conditions, in which targeted specific exercise therapy is now as an evidence-based management strategy with proven effectiveness and patient satisfaction. Thus, referral to physiotherapy would be a natural strategy in women who experience MSK pain as an adverse effect to AI therapy. However, it is unclear if physiotherapeutic treatment has similar effects on AI induced MSK pain as in primary MSK pain. Two systematic review (one with a meta-analysis) have assessed the effect of different pain management strategies for AI-induced MSK-pain and found great uncertainty in the effects of exercise, relaxation techniques and acupuncture. They also found limited evidence on the subject and moderate to low quality of the studies included. The evidence on the subject is clearly limited but the need for a treatment option to minimize the side-effects of the AI medication real and necessary.

Targeted individualised physiotherapeutic treatment is tailored for the affected (painful) tissue/joint/region specifically and is based on extensive experience and evidence from MSK physiotherapy in rheumatic and orthopedic patient population. Targeted individualised physiotherapy treatment take into account the individual patient, her constitution, the painful tissue/region/joint (e.g. its biomechanics, physiological properties, and inflammatory activity), and is adjusted according to day-to-day variations in pain and progressed based on the interaction between changes in symptoms and function and tissue healing. Such approach is expected to yield a greater effect on MSK pain, than a generic exercise program. Further, targeted treatment programs are delivered by trained physiotherapists, who have specific clinical training and experience in clinical management of patient and handling MSK pain, which is also expected to yield better clinical outcomes than programs delivered by people without clinical training.

Altogether it is very likely that a targeted physiotherapy treatment will be of significant benefit to breast cancer survivors with AI induced MSK pain.

The aim is to compare targeted individualized physiotherapeutic treatment and medical care with medical care alone on aromatase inhibitor associated musculoskeletal pain in female breast cancer survivors.

It is hypothesized that targeted physiotherapeutic treatment and medical care reduces musculoskeletal pain significantly in women with aromatase inhibitor associated musculoskeletal pain when compared to medical care alone.

The plan is to include 120 participants from the oncology department at Rigshospitalet, Denmark.

Participants will partake in the study for a total of 26 weeks. During the first 12 week the intervention group will receive the physiotherapeutic treatment twice a week. The medical care visits are place at the first visit to the clinic, week 13 and week 26.

Conditions

• Musculoskeletal Pain

Interventions

OTHER

Physiotherapeutic treatment and medical care

Physiotherapeutic treatment twice a week for twelve weeks and medical care three times at baseline, week 13 and week 26

OTHER

medical care

medical care three times during the study period; baseline, week 13 and week 26

Sponsors & Collaborators

• Frederiksberg University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-14

Primary Completion

2024-01-04

Completion

2024-04-04

Countries

• Denmark

Study Locations