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Active not recruitingNAINTERVENTIONAL

Effects of Isolated Lumbar Extension Resistance Training Alone and in Combination with General Exercise and Manual Therapy

This study is investigating a special type of exercise for people who have been suffering from low back pain for a long time. It focuses on an exercise system that strengthens specific muscles in the lower back using a machine (called ILEX). Researchers want to see if this exercise alone helps improve back muscle strength and shape, reduces pain, and makes daily life better. They also want to know if combining this special exercise with general exercise and hands-on therapy works even better. The study aims to understand the best way to use this targeted exercise to help people with ongoing back problems.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University of Wuerzburg
Enrolment target
72
Start
01 Dec 2021
Estimated completion
24 Jun 2025

What is this study about?

If you've been living with ongoing low back pain, you know how much it can affect your daily life. This study is designed to explore how a specific type of exercise might help. It focuses on strengthening the deep muscles in your lower back using a special machine. This machine targets muscles that are often weakened in people with back pain.

The researchers are interested in two main questions. First, does using this machine on its own help to make your back muscles stronger and healthier, reduce your pain, and improve your overall well-being? Second, do you get even better results if you combine this machine-based exercise with other common treatments for back pain, like general exercise and hands-on gentle movements from a therapist? Doctors often suggest a combined approach for long-term back pain, and this study aims to find out the best way to put these ideas into practice.

Understanding which treatments are most effective can help doctors and therapists provide better care for people with ongoing back pain. By taking part, you could contribute to this important knowledge, potentially helping many others in the future.

Key takeaways

  • Investigating a special back strengthening exercise.
  • Comparing it alone versus with other therapies for long-term back pain.
  • Looks at muscle health, pain, and quality of life.
  • Involves exercise sessions for 16 weeks with follow-up.
  • Aims to find better ways to treat ongoing back pain.

Who may be eligible?

To join this study, you need to have been experiencing low back pain for at least three months. This pain can be in the area between your lower ribs and your bottom, and it might also spread down your leg. You'll need to be seeing a doctor or specialist at the study's facility for your back pain, and they will confirm that your symptoms are related to specific issues like a slipped disc.

Your pain levels should be moderate when the doctor assesses you to make sure the study applies to people with noteworthy discomfort. The study is open to both men and women aged between 18 and 65 years old.

You cannot take part if your back pain started less than three months ago, if you've used the specific exercise device (ILEX) in the last year, or if you have any broken bones.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have I had low back pain for at least three months?
  2. Do I currently have moderate pain levels?
  3. Am I between 18 and 65 years old?
  4. Has a doctor confirmed my back pain is due to a specific spinal problem?
  5. Have I NOT used the specific back exercise machine in the last year?
  6. Do I NOT have any broken bones?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups. Both groups will follow a specific exercise plan using a machine that strengthens your lower back muscles. This will involve 25 exercise sessions over 16 weeks.

One group will have these machine-based exercises, while the other group will have the same machine-based exercises plus additional general exercise and hands-on therapy from a specialist. The exact number of general exercise and therapy sessions will be explained to you. After these 16 weeks, you'll be given options to continue some exercise at a reduced pace (for example, once a month).

There will be follow-up appointments six months after the main exercise program finishes to see how you're doing in the long term. Throughout the study, various assessments will be performed to measure your back muscle health, pain levels, and how your back pain affects your daily life.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a reduction in your back pain, improved muscle strength, and a better quality of life. The exercises are designed to be safe, but as with any physical activity, there's a small chance of muscle soreness or mild discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • University of Wuerzburg, Institute of Sports Science
    Verified postcode
    Würzburg, Germany

Common questions

What is 'ILEX'?

ILEX is a special kind of machine-based exercise that focuses on strengthening specific muscles in your lower back.

How long will the study last?

The main exercise program is 16 weeks long, followed by a six-month check-up.

Will I know which group I'm in?

You will be assigned to a group either receiving the special exercise alone or with additional general exercise and hands-on therapy.

What kind of back pain is this study for?

This study is for people who have had low back pain for more than three months, which may include leg pain.

Do I have to live near the study facility to join?

Yes, you need to be seeking care at the specific facility where the study is being conducted.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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