 |
| Pilot study Backstretcher For 12 patients | |
| |
2
2. Chronically severe back complaints6 (pilot study)
For 12 patients, who are being treated for chronically severe non-specific back complaints by a general practitioner (J. van Niekerk) and a physiotherapist (M. van Straten), the Backstretcher has been added to the treatment protocol, in which the emphasis was already on anti-kyphosis, under the direction of a physiotherapist. After two weeks, 11/12 of the patients showed drastic improvement, 3 patients did not even have any complaints whatsoever. The results may be summarized as follows:
|
|
Complaint score |
|
Extremely severe |
Severe |
Moderate |
Slight |
Very slight |
None |
|
Beforehand |
4 |
5 |
3 |
|
|
|
|
After 2 weeks |
1 |
1 |
1 |
3 |
3 |
3 |
For 4 patients, the evaluation was extended by two weeks and further improvement could be observed:
|
|
Complaint score |
|
Extremely severe |
Severe |
Moderate |
Slight |
Very slight |
None |
|
After 2 weeks |
|
1 |
|
1 |
2 |
|
|
After 4 weeks |
|
|
1 |
|
1 |
2 |
Currently, 13 to 15 months after the commencement of this pilot study, the Backstretcher is still used by the (former) patients. So far, no patients have reported to either general practitioner or physiotherapist with recurrence.
The conclusion of this research and its follow-up is that the Backstretcher has a positive effect on most patients with chronically severe back complaints - under which antikyphosis is considered to be indicated - and with regular use this effect can continue for years.
|
| Chronic moderate back complaints For 28 people | |
| |
3
3. Chronic moderate back complaints7
For 28 people taking part in the company fitness programme of the Provinciehuis (County Hall) Utrecht and suffering from low back complaints (subjective) and intensified thoracic kyphosis (objective), the Backstretcher was added to the regular company fitness programme for a period of 4 weeks. In this study, carried out by the physiotherapist P. Verweij, not only the degree of back complaints was looked into, but also the improvement of work restriction, if this existed. This is done with an eye on the importance of productivity and in order to prevent resignation.
The most important results are listed in the table below:
|
|
Total number |
Complaints
worse |
Complaints unchanged |
Complaints
improved <50% |
Complaints improved >=50% |
Complaints disappeared |
|
Back complaints |
28 |
0 0% |
3 11% |
2 7% |
21 75% |
2 7% |
|
Work restriction |
21 |
2 10% |
1 5% |
0 0% |
3 14% |
15 71% |
|
ADL restriction |
24 |
0 0% |
2 8% |
1 4% |
9 38% |
12 50% |
Conclusion from these results is that the Backstretcher causes an very relevant improvement of the complaints with approximately 90% of the people with chronic moderate complaints. These results confirm the findings of the study with severe patients.
However, the additional functional improvement is extremely important: of the people who were formerly restricted in their work, over 80% is free of restrictions at the end of the research period.
|
| Relaxation. The Backstretcher and Yoga | |
| |
5
5. Relaxation9,10
It has been suggested from different sides that the Backstretcher should be able to play a part in relaxing and fighting stress. In the first place, the Backstretcher is used intensively for this purpose in Japan. In the second place, HELPmedical regularly receives feedback from users about the "relaxing effects". Furthermore, 9 out of 28 participants in the study (P. Verweij) who suffered from moderate chronic back complaints, spontaneously mentioned this relaxing effect. Finally, HELPmedical is frequently approached by Yoga therapists with the question whether the Backstretcher would be useful in their field.
These suggestions concerning the possible relaxing effect have led to two studies, the first in a "cool-down" situation after taking part in an intensive aerobics lesson, the second in a yoga environment, on the one hand to prepare for a meditation session, on the other hand after a yoga session.
The results underline the relaxing effect of the Backstretcher which has been suggested, as illustrated by the following data [Backstretcher has been abbreviated to BS]:
|
Cool-down |
n=147 |
Lying on BS for
15 minutes after aerobics lesson |
59% enjoy cool-down on BS (very much)
77% find BS (very) relaxing
|
|
Yoga |
n=60 |
Lying on BS for
15 minutes after yoga lesson |
85% prefer BS to lying on the ground
75% consider BS to add to the yoga lesson
100% of the people with back complaints report spontaneous improvement of complaints
|
|
|
n=60 |
Lying on BS for
10 minutes prior to Zen meditation |
100% find lying on BS a good preparation for meditation
100% report that the meditation position is easier to assume and to maintain; this was also found by the yoga teacher
|
Conclusion from these studies is that lying on the Backstretcher has a relaxing effect on most users.
|
| Post Marketing Surveillance on 400 persons . | |
| |
6
6. Post Marketing Surveillance11
There are three limitations to the prospective studies with the Backstretcher that have been described above: limited research populations and duration of study, together with an open, uncontrolled design of the study.
In order to reinforce the foundations of the Backstretcher, a Post Marketing Surveillance was carried out in the period July-August 1996. For this, the first 800 people (read: patients) who bought the Backstretcher since October 1995, were approached. This group was approached by letter with a questionnaire. On 31 August 1996, the response was closed for a first analysis, in which (of a total response of 383 people), 378 people were included who could be evaluated (in accordance with a highly satisfactory response of 47.3%).
Generally speaking, the research population can be described as follows:
|
Number of respondents |
378 |
|
Duration of
back complaints |
3% |
< 6 months |
|
Proportion Male:Female |
56:44 |
|
7% |
6-12 months |
|
Age |
47.2 years [15-85] |
|
6% |
1-2 years |
|
Period of using Backstretcher |
5.8 months [4-14] |
|
84% |
> 2 years |
A remarkable aspect of the general inventory is that the respondents were treated by an average of 1.95 (para)medics at the time of purchasing the Backstretcher. This emphasizes the unsolved problem most patients have and also illustrates that creating a therapeutical policy is not easy in a situation where an average of two (sometimes up to 5!) professionals are working.
The results with the Backstretcher are illustrated in the following tables:
|
|
Duration back complaints |
|
< 6 months |
6-12 months |
1-2 years |
> 2 years |
|
Responder rate |
83 % |
87 % |
79 % |
72 % |
|
Improvement pain score |
85 % |
68 % |
53 % |
55 % |
|
|
Pain score |
|
Very severe |
Severe |
Moderate |
Slight |
None |
|
Before the Backstretcher |
30 |
158 |
157 |
33 |
0 |
|
50 % |
|
9 % |
|
Now, with the Backstretcher |
4 |
35 |
108 |
182 |
47 |
|
10 % |
|
61 % |
|
|
Restriction in work |
|
Very severe |
Severe |
Moderate |
Slight |
None |
|
Before the Backstretcher |
27 |
110 |
133 |
81 |
27 |
|
36 % |
|
29 % |
|
Now, with the Backstretcher |
6 |
31 |
80 |
145 |
115 |
|
10 % |
|
69 % |
In addition to the specific results mentioned above, the following overall rating for effectiveness was reported within the entire group of users (including the non-responders):
|
Excellent effect |
10 % |
|
|
Good effect |
29 % |
68 % |
|
Sufficient effect |
29 % |
|
|
Moderate effect |
14 % |
|
|
Slight effect |
8 % |
32 % |
|
No effect |
10 % |
|
Finally, at the time of the Post Marketing Surveillance the Backstretcher is applied by its users as follows:
|
Daily |
172 |
46 % |
|
|
Regularly |
80 |
21 % |
average 3.3 times/week |
|
From time to time |
93 |
25 % |
|
|
Other/not |
33 |
9 % |
|
Conclusion of this large retrospective, long-term study is that it confirms the results of the prospective studies: the Backstretcher is very effective for most of the patients with non-specific chronic back complaints. This Post Marketing Surveillance also shows that any existing work restriction decreases significantly. Finally, the patient compliance for the Backstretcher is extremely high.
Summarizing, it may be said that a large retrospective study confirmed that which has been found in a number of smaller prospective studies:
1. The Backstretcher is, kinesiologically speaking, an acceptable appliance in treating back complaints which go along with intensified thoracic kyphosis.
2. The Backstretcher is very effective in fighting chronically severe and moderate back complaints, both in the responder rate and in symptomatic improvement.
3. The effectiveness of the Backstretcher concerning back complaints seems to be maintained with continuous use.
4. The Backstretcher is a promising appliance for taking away restrictions in work. It can therefore not only serve a medical, but also a very important socio-economic purpose.
5. The patient compliance concerning the use of the Backstretcher is high, which gives secondary and indirect support to the effectiveness that has been established.
6. The Backstretcher can be applied successfully in fighting (muscle) tension and stress.
7. No effectiveness should be expected from the Backstretcher in the case of irreversible immobility of the spine.
8. The Backstretcher is not known to have any negative effects. 11. Post Marketing Surveillance onder 400 personen, die vanwege chronische rugklachten sinds 6 maanden
gebruik maken van de Backstretcher; R.S. Neeter; 1996; data on file
|
|
|
| Mark
van Straten |
Vragen aan fysiotherapeut
Mark van Straten. |
